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Performance evaluation of Gallium-68 radiopharmaceuticals production using liquid target PETtrace 800 cyclotron

Ashhar Z, Ahmad Fadzil MF, Md Safee Z, Aziz F, Ibarhim UH, Nik Afinde NMF, et al.

Appl Radiat Isot, 2024 Mar;205:111161.
PMID: 38163386 DOI: 10.1016/j.apradiso.2023.111161

Due to increased demand, cyclotron has an expanding role in producing Gallium-68 (68Ga) radiopharmaceuticals using solid and liquid targets. Though the liquid target produces lower end-of-bombardment activity compared to the solid target, our study presents the performance of 68Ga radiopharmaceuticals production using the liquid target by evaluating the end-of-bombardment activity and the end-of-purification activity of [68Ga]GaCl3. We also present the effect of increasing irradiation time, which significantly improves the end-of-synthesis yield. From the result obtained, the end-of-bombardment activity produced was 4.48 GBq, and the [68Ga]GaCl3 end-of-purification activity produced was 2.51 GBq with below-limit metallic impurities. Increasing the irradiation time showed a significant increase in the end-of-synthesis activity from 1.33 GBq to 1.95 GBq for [68Ga]Ga-PSMA-11 and from 1.13 GBq to 1.74 GBq for [68Ga]Ga-DOTA-TATE. Based on the improvements made, the liquid target production of 68Ga radiopharmaceuticals is feasible and reproducible to accommodate up to 5 patients per production. In addition, this work also discusses the issues encountered, together with the possible corrective and preventative measures.

Matched MeSH terms: Gallium Radioisotopes*
Fulltext Evidence of Enriched, Hadean Mantle Reservoir from 4.2-4.0 Ga zircon xenocrysts from Paleoarchean TTGs of the Singhbhum Craton, Eastern India

Chaudhuri T, Wan Y, Mazumder R, Ma M, Liu D

Sci Rep, 2018 May 04;8(1):7069.
PMID: 29728630 DOI: 10.1038/s41598-018-25494-6

Sensitive High-Resolution Ion Microprobe (SHRIMP) U-Pb analyses of zircons from Paleoarchean (~3.4 Ga) tonalite-gneiss called the Older Metamorphic Tonalitic Gneiss (OMTG) from the Champua area of the Singhbhum Craton, India, reveal 4.24-4.03 Ga xenocrystic zircons, suggesting that the OMTG records the hitherto unknown oldest precursor of Hadean age reported in India. Hf isotopic analyses of the Hadean xenocrysts yield unradiogenic 176Hf/177Hfinitial compositions (0.27995 ± 0.0009 to 0.28001 ± 0.0007; ɛHf[t] = -2.5 to -5.2) indicating that an enriched reservoir existed during Hadean eon in the Singhbhum cratonic mantle. Time integrated ɛHf[t] compositional array of the Hadean xenocrysts indicates a mafic protolith with 176Lu/177Hf ratio of ∼0.019 that was reworked during ∼4.2-4.0 Ga. This also suggests that separation of such an enriched reservoir from chondritic mantle took place at 4.5 ± 0.19 Ga. However, more radiogenic yet subchondritic compositions of ∼3.67 Ga (average 176Hf/177Hfinitial 0.28024 ± 0.00007) and ~3.4 Ga zircons (average 176Hf/177Hfinitial = 0.28053 ± 0.00003) from the same OMTG samples and two other Paleoarchean TTGs dated at ~3.4 Ga and ~3.3 Ga (average 176Hf/177Hfinitial is 0.28057 ± 0.00008 and 0.28060 ± 0.00003), respectively, corroborate that the enriched Hadean reservoir subsequently underwent mixing with mantle-derived juvenile magma during the Eo-Paleoarchean.

Matched MeSH terms: Gallium Radioisotopes
Fulltext Preparation, Characterization, and Radiolabeling of [68Ga]Ga-NODAGA-Pamidronic Acid: A Potential PET Bone Imaging Agent

Ashhar Z, Yusof NA, Ahmad Saad FF, Mohd Nor SM, Mohammad F, Bahrin Wan Kamal WH, et al.

Molecules, 2020 Jun 09;25(11).
PMID: 32526838 DOI: 10.3390/molecules25112668

Early diagnosis of bone metastases is crucial to prevent skeletal-related events, and for that, the non-invasive techniques to diagnose bone metastases that make use of image-guided radiopharmaceuticals are being employed as an alternative to traditional biopsies. Hence, in the present work, we tested the efficacy of a gallium-68 (68Ga)-based compound as a radiopharmaceutical agent towards the bone imaging in positron emitting tomography (PET). For that, we prepared, thoroughly characterized, and radiolabeled [68Ga]Ga-NODAGA-pamidronic acid radiopharmaceutical, a 68Ga precursor for PET bone cancer imaging applications. The preparation of NODAGA-pamidronic acid was performed via the N-Hydroxysuccinimide (NHS) ester strategy and was characterized using liquid chromatography-mass spectrometry (LC-MS) and tandem mass spectrometry (MSn). The unreacted NODAGA chelator was separated using the ion-suppression reverse phase-high performance liquid chromatography (RP-HPLC) method, and the freeze-dried NODAGA-pamidronic acid was radiolabeled with 68Ga. The radiolabeling condition was found to be most optimum at a pH ranging from 4 to 4.5 and a temperature of above 60 °C. From previous work, we found that the pamidronic acid itself has a good bone binding affinity. Moreover, from the analysis of the results, the ionic structure of radiolabeled [68Ga]Ga-NODAGA-pamidronic acid has the ability to improve the blood clearance and may exert good renal excretion, enhance the bone-to-background ratio, and consequently the final image quality. This was reflected by both the in vitro bone binding assay and in vivo animal biodistribution presented in this research.

Matched MeSH terms: Gallium Radioisotopes/pharmacokinetics*; Gallium Radioisotopes/chemistry
68Ga-prostate specific membrane antigen-11 PET/CT versus multiparametric MRI in the detection of primary prostate cancer: A systematic review and head-to-head comparative meta-analysis

Ren X, Nur Salihin Yusoff M, Hartini Mohd Taib N, Zhang L, Wang K

Eur J Radiol, 2024 Jan;170:111274.
PMID: 38147764 DOI: 10.1016/j.ejrad.2023.111274

PURPOSE: The goal of this study was to evaluate the effectiveness of two diagnostic methods, 68Ga-PSMA-11 PET/CT and mpMRI, in detecting primary prostate cancer without limitations on the Gleason score.
METHODS: We conducted a comprehensive literature review, searching databases such as PubMed, Embase, and Web of Science until June 2023. Our objective was to identify studies that compared the efficacy of 68Ga-PSMA-11 PET/CT and mpMRI in detecting primary prostate cancer. To determine heterogeneity, the I2 statistic was used. Meta-regression analysis and leave-one-out sensitivity analysis were conducted to identify potential sources of heterogeneity.
RESULTS: Initially, 1286 publications were found, but after careful evaluation, only 16 studies involving 1227 patients were analyzed thoroughly. The results showed that the 68Ga-PSMA-11 PET/CT method had a pooled sensitivity and specificity of 0.87 (95 % CI: 0.80-0.92) and 0.80 (95 % CI: 0.69-0.89), respectively, for diagnosing prostatic cancer. Similarly, the values for mpMRI were determined as 0.84 (95 % CI: 0.75-0.92) and 0.74 (95 % CI: 0.61-0.86), respectively. There were no significant differences in diagnostic effectiveness observed when comparing two primary prostate cancer methodologies (pooled sensitivity P = 0.62, pooled specificity P = 0.50). Despite this, the funnel plots showed symmetry and the Egger test results (P values > 0.05) suggested there was no publication bias.
CONCLUSIONS: After an extensive meta-analysis, it was found that both 68Ga-PSMA-11 PET/CT and mpMRI demonstrate similar diagnostic effectiveness in detecting primary prostate cancer. Future larger prospective studies are warranted to investigate this issue further.

Matched MeSH terms: Gallium Radioisotopes
The role of 67gallium scintigraphy and high resolution computed tomography as predictors of disease activity in sputum smear-negative pulmonary tuberculosis

Lai FM, Liam CK, Paramsothy M, George J

Int J Tuberc Lung Dis, 1997 Dec;1(6):563-9.
PMID: 9487455

University Hospital, Kuala Lumpur, Malaysia.

Matched MeSH terms: Gallium Radioisotopes*
Fulltext Mastoiditis secondary to mycobacterium abscessus imaged with gallium-67 scintigraphy

Vijayananthan A, Arumugam A, Kumar G, Harichandra D

Biomed Imaging Interv J, 2008 Apr;4(2):e23.
PMID: 21614326 MyJurnal DOI: 10.2349/biij.4.2.e23

Atypical mycobacterium is rarely seen as a cause of chronic mastoiditis but has been increasingly recognized over the past few years. Mycobacterium abscessus is the most pathogenic and chemotherapy-resistant, rapid-growing mycobacterium of all the four groups. This paper presents a case of a 57-year-old woman who had chronic mastoiditis with recurrent exacerbations. The initial computed tomography (CT) findings showed the presence of an inflammatory process and she was treated with the appropriate antibiotics. The patient subsequently underwent a tissue biopsy when she presented with another exacerbation. At this time, the CT scan did not identify the ongoing exacerbation, but the Gallium-67 scintigraphy did.

Matched MeSH terms: Gallium Radioisotopes
ASSESSMENT OF PATIENT'S RADIATION EXPOSURES RESULTED FROM PET/CT 18F-FCH AND 68GA-PSMA PROCEDURES

Salah H, Al-Mohammed HI, Mayhoub FH, Sulieman A, Alkhorayef M, Abolaban FA, et al.

Radiat Prot Dosimetry, 2021 Oct 12;195(3-4):349-354.
PMID: 34144608 DOI: 10.1093/rpd/ncab077

This study has sought to evaluate patient exposures during the course of particular diagnostic positron emission tomography and computed tomography (PET/CT) techniques. A total of 73 patients were examined using two types of radiopharmaceutical: 18F-fluorocholine (FCH, 48 patients) and 68Ga-prostate-specific membrane antigen (PSMA, 25 patients). The mean and range of administered activity (AA) in MBq, and effective dose (mSv) for FCH were 314.4 ± 61.6 (462.5-216.8) and 5.9 ± 1.2 (8.8-4.11), respectively. Quoted in the same set of units, the mean and range of AA and effective dose for 68Ga-PSMA were 179.3 ± 92.3 (603.1-115.1) and 17.9 ± 9.2 (60.3-11.5). Patient effective doses from 18F-FCH being a factor of two greater than the dose resulting from 68Ga-PSMA PET/CT procedures. CT accounts for some 84 and 23% for 18F-FCH and 68Ga-PSMA procedures, accordingly CT acquisition parameter optimization is recommended. Patient doses have been found to be slightly greater than previous studies.

Matched MeSH terms: Gallium Radioisotopes
Fulltext A Case of Appendiceal Goblet Cell Carcinoid Tumor: Getting it right under the Microscope

Kang WH, Wahab NA, Kamaruddin NA

J ASEAN Fed Endocr Soc, 2020;35(1):102-104.
PMID: 33442175 DOI: 10.15605/jafes.035.01.16

Goblet cell carcinoid (GCC) is a rare neoplasm of the vermiform appendix and can be mistaken as a typical neuroendocrine tumour (TNET). The natural history of this disease is more aggressive compared to TNETs and requires a more aggressive approach. We report a case of a 37-year-old male who was initially diagnosed with TNET, but subsequently revised as Tang's A GCC. He underwent appendectomy and right hemicolectomy. Aside from a persistently elevated carcinoembyrogenic antigen (CEA) result, his 18F-fluorodeoxyglucose (FDG) PET/CT and a 68-Gallium DOTATATE PET/CT scan showed no FDG or DOTATATE avid lesions.

Matched MeSH terms: Gallium Radioisotopes
Fulltext Use of gallium-67 in the assessment of response to antibiotic therapy in malignant otitis externa--a case report

Paramsothy M, Khanijow V, Ong TO

Singapore Med J, 1997 Aug;38(8):347-9.
PMID: 9364890

Malignant Otitis Externa (MOE) can cause considerable morbidity and mortality in affected individuals. The outlook is now much improved with the use of ciprofloxacin, but it is important to ascertain that the infection has been completely eradicated before stopping treatment, as undertreatment may lead to a recurrence which is usually more resistant than the initial infection. Gallium-67 Single Photon Emmision Computerised Tomography (SPECT) is a sensitive and cost effective tool in monitoring the disease activity of MOE, and should be used in the assessment of the response to antibiotic therapy.

Matched MeSH terms: Gallium Radioisotopes*
The quantification of PET-CT radiotracers to determine minimal scan time using quadratic formulation

Said MA, Musarudin M, Zulkaffli NF

Ann Nucl Med, 2020 Dec;34(12):884-891.
PMID: 33141408 DOI: 10.1007/s12149-020-01543-x

OBJECTIVE: 18F is the most extensively used radioisotope in current clinical practices of PET imaging. This selection is based on the several criteria of pure PET radioisotopes with an optimum half-life, and low positron energy that contributes to a smaller positron range. In addition to 18F, other radioisotopes such as 68Ga and 124I are currently gained much attention with the increase in interest in new PET tracers entering the clinical trials. This study aims to determine the minimal scan time per bed position (Tmin) for the 124I and 68Ga based on the quantitative differences in PET imaging of 68Ga and 124I relative to 18F.
METHODS: The European Association of Nuclear Medicine (EANM) procedure guidelines version 2.0 for FDG-PET tumor imaging has adhered for this purpose. A NEMA2012/IEC2008 phantom was filled with tumor to background ratio of 10:1 with the activity concentration of 30 kBq/ml ± 10 and 3 kBq/ml ± 10% for each radioisotope. The phantom was scanned using different acquisition times per bed position (1, 5, 7, 10 and 15 min) to determine the Tmin. The definition of Tmin was performed using an image coefficient of variations (COV) of 15%.
RESULTS: Tmin obtained for 18F, 68Ga and 124I were 3.08, 3.24 and 32.93 min, respectively. Quantitative analyses among 18F, 68Ga and 124I images were performed. Signal-to-noise ratio (SNR), contrast recovery coefficients (CRC), and visibility (VH) are the image quality parameters analysed in this study. Generally, 68Ga and 18F gave better image quality as compared to 124I for all the parameters studied.
CONCLUSION: We have defined Tmin for 18F, 68Ga and 124I SPECT CT imaging based on NEMA2012/IEC2008 phantom imaging. Despite the long scanning time suggested by Tmin, improvement in the image quality is acquired especially for 124I. In clinical practice, the long acquisition time, nevertheless, may cause patient discomfort and motion artifact.

Matched MeSH terms: Gallium Radioisotopes/chemistry
Fulltext Effective Dose Estimation of Patients Administered with 18F-FDG and Ga-68 DOTATATE in PET/CT Examination Associated with Gender and Weight

Kamal, I., Said, M. A., Bathumalai, J., Abdul Razak, H. R., Abdul Karim, M. K.

Physics and Technology in Medicine, 2020;1(1):15-21.
MyJurnal

The whole-body fluorodeoxyglucose F18 (18F-FDG) and gallium-68 (Ga-68 DOTATATE) are the most common radiopharmaceutical use in PET/CT imaging for cancer staging. Although radiopharmaceutical for PET/CT examination has been acknowledged for its safety and efficacy, the internal dosimetry and effective dose (ED) from the examinations are rarely discussed. Hence, this study aimed to evaluate radiation ED for whole-body radiopharmaceuticals PET/CT concerning patients’ gender and their weight. A total of 82 oncology patients (44 males and 38 females) were collected retrospectively from Institut Kanser Negara, Putrajaya. Data, such as 18F-FDG and Ga-68 DOTATATE activity and patient demography (weight, height, age), were recorded and analyzed. Effective doses from both internal and external exposure were calculated using the coefficient
provided by the International Commission on Radiological Protection (ICRP) report. The total ED of 18F-FDG for male patients was 20.2 ± 8.6 mSv and for female patients were 19.0 ± 8.2 mSv while total whole-body ED for Ga-68 DOTATATE for male patients was 18.5 ± 7.0 mSv and 17.0 ± 5.6 mSv for female patients. The ratio for ED between male and female were 1:1 for both examinations ranged from 12.0 – 23 mSv. From this study, it indicated that the ED of Ga-68 DOTATATE was far lower when compared to the ED of 18F-FDG by a factor of 0.7. Therefore, it is crucial to optimize the PET/CT protocol dose in order to uphold the dose as low as reasonably achievable (ALARA).

Matched MeSH terms: Gallium Radioisotopes
Fulltext Neuroendocrine tumour of the lung: a diagnostic challenge

Nur Hidayah Bahrom, Anis Safura Ramli, Nor Suraya Samsudin, Norliana Dalila Mohamad Ali, Nor Salmah Bakar

Journal of Clinical and Health Sciences, 2019;4(2):97-104.
MyJurnal

This is a case of a 62-year-old Indian man who was diagnosed with a rare type of lung
neuroendocrine tumour (NET) of atypical carcinoid (AC) subtype which comprises only 0.1%–
0.2% of pulmonary neoplasms. He initially presented to a private hospital in May 2018 with a
6-month history of chronic productive cough and haemoptysis. Chest X-Ray (CXR), CT scan,
bronchoscopy, biopsy and broncho-alveolar lavage were conducted. At this stage, imaging and
histopathological investigations were negative for malignancy. Diagnosis of bronchiectasis was
made and he was treated with antibiotic and tranexamic acid. Due to financial difficulties, his
care was transferred to a university respiratory clinic in June 2018. His condition was monitored
with CXR at every visit and treatment with tranexamic acid was continued for 6 months.
However, due to persistent haemoptysis, he presented to the university primary care clinic in
Dec 2018. Investigations were repeated in January 2019 where his CXR showed increased
opacity of the left retrocardiac region and CT scan revealed a left lower lobe endobronchial
mass causing collapse with mediastinal lymphadenopathy suggestive of malignancy.
Bronchoscopy, biopsy and histopathology confirmed the presence of NET. Although the Ki-67
index was low, the mitotic count, presence of necrosis and evidence of liver metastases
favoured the diagnosis of AC. A positron emission tomography Ga-68 DONATOC scan showed
evidence of somatostatin receptor avid known primary malignancy in the lungs with suspicions
of liver metastasis. He was subsequently referred to the oncology team and chemotherapy was
initiated. This case highlights the challenge in diagnosis and management of patients with AC.
Physicians ought to be vigilant and have a high index of suspicion in patients who present with
persistent symptoms on multiple visits. Early diagnosis of NET would prevent metastasis and
provide better prognosis. Continuous follow-up shared care between primary care and
secondary care physicians is also essential to provide ongoing psychosocial support for
patients with NET, especially those with metastatic disease

Matched MeSH terms: Gallium Radioisotopes

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