Drug updated on 9/5/2024
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.
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Summary
- Choline C 11 Injection (choline c 11 injection) is 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.
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-6]
- PSMA-targeted imaging demonstrated superior diagnostic performance in primary and recurrent prostate cancer compared to [11C]choline and [18F]FACBC, though it is limited by heterogeneity in PSMA expression. 4. [11C]choline PET showed high sensitivity (71-84%) and specificity (86%) in detecting local and regional recurrences post-radical prostatectomy and achieved detection rates of up to 31.3% in early recurrent prostate cancer with PSA levels <0.5ng/ml.
- In high-grade glioma, [11C]choline PET demonstrated 100% sensitivity and 70-88% specificity in differentiating tumor progression from treatment-related changes.
- There is no safety information available in the reviewed studies.
- There is no population types or subgroups information available in the reviewed studies.
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 |