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NCT02678351 · ClinicalTrials.gov registry record · Phase 2

68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery

A Phase 2 study, sponsored by Andrei Iagaru.

Completed
Registry status
Phase 2
Development phase
74
Enrollment target

NCT02678351: Completed Phase 2 study, sponsored by Andrei Iagaru.

NCT02678351 is a Phase 2 study that has completed, run by Andrei Iagaru. The registered enrollment target is 74 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02678351, a Phase 2 study, has completed, sponsored by Andrei Iagaru.

COMPLETED
Registry status
Phase 2
Development phase
74 participants
Enrollment target

Study Summary

This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.

Primary Outcome

68-gallium (68Ga)-prostate-specific membrane antigen (PSMA) positron emission tomography/magnetic resonance imaging (PET/MRI) will be used to detect regional nodal and distant metastases in participants with intermediate and high-risk prostate cancer scheduled to undergo prostatectomy with lymph node dissection. The data will be analyzed by imaging interpretation. Each participant will be interpreted as either positive or negative for the presence of metastatic disease by 68Ga-PSMA PET/MRI, as a

Interventions

  • PROCEDURE Magnetic resonance imaging (MRI)
  • DRUG 68Ga-PSMA-11
  • PROCEDURE Positron Emission Tomography (PET)

Trial Details

FieldValue
Enrollment Target 74 participants
Start Date 2016-04-18
Est. Completion 2021-12
Phase Phase 2
Andrei Iagaru

13 total trials

What the finished NCT02678351 record still lists

NCT02678351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

The record links to 0 conditions, and to 3 interventions - of which Magnetic resonance imaging (MRI) is the first listed.

NCT02678351 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02678351 about?

NCT02678351 is a clinical study titled "68Ga-PSMA-11 PET/MRI in Finding Tumors in Patients With Intermediate or High-Risk Prostate Cancer Undergoing Surgery". This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostica...

What is the current status of trial NCT02678351?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2016-04-18. Estimated completion is 2021-12.

What interventions are being tested in trial NCT02678351?

The interventions under investigation include: Magnetic resonance imaging (MRI) (PROCEDURE), 68Ga-PSMA-11 (DRUG), Positron Emission Tomography (PET) (PROCEDURE).

Who is sponsoring clinical trial NCT02678351?

This trial is sponsored by Andrei Iagaru, which has 13 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02678351's enrollment target sits among peer trials

74 920th of 2000 higher than 1,077 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02678351, the US trial registry maintained by the National Library of Medicine. NCT02678351 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.