Drug updated on 4/15/2024
| Dosage Form | Injection (intravenous; 48 MBq to 1225 MBq [4 mCi to 33.1 mCi]) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for positron emission tomography (PET) imaging of patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging. In these patients, 11 C-choline PET imaging may help identify potential sites of prostate cancer recurrence for subsequent histologic confirmation. Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
Summary
- Choline C 11 Injection is a radiotracer used in positron emission tomography (PET) imaging, particularly indicated for patients with suspected prostate cancer recurrence when other imaging modalities like bone scintigraphy, CT, or MRI are non-informative.
- Eight studies were reviewed to gather information about the drug's indication and its comparison with other tracers.
- PSMA-targeted agents demonstrated superior diagnostic performance in both primary and recurrent prostate cancer compared to Choline C 11. However, Choline C 11 has shown significant utility in detecting local and regional recurrences post-radical prostatectomy, especially when combined with PET/MRI or PET/CT techniques.
- In terms of sensitivity and specificity, Choline C 11 was noted for reasonable pooled sensitivities (71%) and high specificity (86%), suggesting an effective balance between correctly identifying true positives while minimizing false positives.
- Subgroup considerations reveal that detection rates improve with increasing PSA levels but are overtaken by superior detection rates of PSMA-PET tracers at very low PSA subgroup. Additionally, PET tracers, including Choline C 11, have also been evaluated for brain tumors indicating an evolving role across oncology.
- While safety comparisons between Choline C 11 injection and other drugs/tracers were not detailed specifically; given its FDA approval status, a favorable safety profile within the clinical application range can be inferred, considering factors such as pharmacokinetics, minimal effective dose required for accurate imaging, and patient-specific factors like renal clearance and potential allergic reactions.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Choline C 11 Injection prescribing information. | 2012 | Mayo Clinic PET Radiochemistry Facility, Rochester, MN |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| EAU-EANM-ESTRO-ESUR-ISUP-SIOG guidelines on prostate cancer. | 2023 | European Association of Urology |
| Optimum imaging strategies for advanced prostate cancer: ASCO guideline. | 2020 | American Society of Clinical Oncology |