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NCT02624518 · ClinicalTrials.gov registry record · Phase 2
68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer
A Phase 2 study of Prostate Adenocarcinoma, sponsored by Andrei Iagaru.
- Completed
- Registry status
- Phase 2
- Development phase
- 122
- Enrollment target
- 1
- Study location
NCT02624518 is a Phase 2 study of Prostate Adenocarcinoma that has completed, run by Andrei Iagaru. The registered enrollment target is 122 participants, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02624518, a Phase 2 study of Prostate Adenocarcinoma, has completed, sponsored by Andrei Iagaru.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 122 participants
- Enrollment target
- 1
- Study location
Study Summary
Prostate cancer (PC) remains the most-common non-cutaneous cancer diagnosed in American males, accounting for an estimated 174,560 estimated new cases and 31,620 estimated deaths in 2019. Up to 40% of the patients with prostate cancer develop biochemical recurrence within 10 years after initial treatment. Usually an increase of the prostate-specific antigen (PSA) llevel precedes a clinically detectable recurrence by months to years, and this is currently used as a screening test before and subsequent to treatment. However, disease advancement can be local, regional or systemic, and each has significantly different approaches to disease management. Unfortunately, PSA level does not differentiate between these disease stages. This phase 2-3 study explores the utility of radiolabel 68Ga-RM2, a 68-gallium (68Ga)-labeled gastrin-releasing peptide receptor (GRPr) antagonist, for positron emission tomography (PET) / magnetic resonance imaging (MRI) (collectively, PET/MRI) as a potential tool to help discriminate between disease stages in participants after treatment with surgery or radiation, who present persistently elevated PSA levels (ie, may have prostate cancer), but were negative for cancer with a diagnostic regular medical care computed tomography (CT) scan 68Ga-RM2 (BAY86-7548) is also identified as a synthetic bombesin receptor antagonist. PET/MRI is the collective result of 2 scan processes (PET and MRI ) conducted during the same scan procedure (ie, a combined scan). After a regular medical care computed tomography (CT) scan, participants will be scanned with 68Ga-RM2 PET/MRI scan procedure. PET/MRI is used to assess the location, size, and metabolic activity of a suspected tumor. The 68Ga-RM2 radiolabel consisted of a ligand (the synthetic bombesin receptor antagonist) and the radioisotope 68Ga. The RM2 ligand targets gastrin-releasing peptide receptors (GRPr), commonly expressed by prostate cancer cells, and the radioisotope distinguishes those cells from t
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Positron Emission Tomography
- DRUG 68Ga-RM2
Study Locations (1)
California
- Stanford University, School of Medicine - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2015-11-16 |
| Est. Completion | 2022-11 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02624518
The ClinicalTrials.gov registry entry for NCT02624518 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 217-participant average among 99 other Prostate Adenocarcinoma trials with a reported enrollment target (44% lower). The listed sponsor is Andrei Iagaru, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Prostate Adenocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT02624518 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02624518 about?
NCT02624518 is a clinical study titled "68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer". Prostate cancer (PC) remains the most-common non-cutaneous cancer diagnosed in American males, accounting for an estimated 174,560 estimated new cases and 31,620 estimated deaths in 2019. Up to 40% of the patients with prostate cancer develop biochemical recurrence within 10 years after initial trea...
What is the current status of trial NCT02624518?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 122 participants. The study started on 2015-11-16. Estimated completion is 2022-11.
What conditions does trial NCT02624518 study?
This clinical trial studies the following conditions: Prostate Adenocarcinoma.
What interventions are being tested in trial NCT02624518?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Positron Emission Tomography (PROCEDURE), 68Ga-RM2 (DRUG).
Who is sponsoring clinical trial NCT02624518?
This trial is sponsored by Andrei Iagaru, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02624518 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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