Clinical trial · Interventional
68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer
68Ga-DOTA-Bombesin PET/MRI in the Evaluation of Patients With Prostate Cancer: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Carcinoma | Prostate Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTA-Bombesin | Drug | — | UNRESOLVED |
| Magnetic Resonance Imaging (MRI) scan | Procedure | — | UNRESOLVED |
| Positron Emission Tomography (PET) scan | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-DOTA-Bombesin PET/MRI
- description
- Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
- interventionNames
- Drug: 68Ga-DOTA-Bombesin
- Procedure: Magnetic Resonance Imaging (MRI) scan
- Procedure: Positron Emission Tomography (PET) scan
Primary outcomes (1)
- measure
- Normal Biodistribution of 68Ga-DOTA-Bombesin
- timeFrame
- 1 hour
- description
- Radiopharmaceutical uptake in normal organs will be evaluated visually and measured semi-quantitatively using standardized uptake values (SUV) derived from the PET/CT scan software in patients with prostate cancer. Uptake values in different tissues will be measured as SUVmean (mean value for SUV). SUVmean values reflect relative uptake of the radiolabel into the tissue.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 19 Years
Show eligibility criteria text
INCLUSION CRITERIA * Provides written informed consent * Known diagnosis of prostate cancer * Patient has suspected recurrence based on biochemical data \[prostate-specific antigen (PSA) \> 2 ng/mL\] * Able to remain still for duration of each imaging procedure (about one hour) EXCLUSION CRITERIA * Unable to provide informed consent * Inability to lie still for the entire imaging time * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance * Metallic implants
References
Publications (1)
- DERIVEDMinamimoto R, Hancock S, Schneider B, Chin FT, Jamali M, Loening A, Vasanawala S, Gambhir SS, Iagaru A. Pilot Comparison of (6)(8)Ga-RM2 PET and (6)(8)Ga-PSMA-11 PET in Patients with Biochemically Recurrent Prostate Cancer. J Nucl Med. 2016 Apr;57(4):557-62. doi: 10.2967/jnumed.115.168393. Epub 2015 Dec 10. PMID 26659347