Phase 2
Completed N=10
68Ga-DOTA-Bombesin PET/MRI in Imaging Patients With Prostate Cancer
Prostate Carcinoma
Source: ClinicalTrials.gov NCT02440308 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Normal Biodistribution of 68Ga-DOTA-Bombesin — 2.28; 121.55; 0.08; 0.10 SUV-mean
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normal Biodistribution of 68Ga-DOTA-Bombesin |
2.28; 121.55; 0.08; 0.10; 0.70; 0.25 | — |
| SECONDARY 68Ga-DOTA-Bombesin Feasibility |
100 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02440308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.