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NCT03675451 · ClinicalTrials.gov registry record · Phase 2

PSMA Imaging of Localized Prostate Cancer

A Phase 2 study of Prostate Cancer, sponsored by Weill Medical College of Cornell University.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT03675451 is a Phase 2 study of Prostate Cancer that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 20 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03675451, a Phase 2 study of Prostate Cancer, has completed, sponsored by Weill Medical College of Cornell University.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

The present study is a phase II, open label, single-center, non-randomized, single-dose study. Twenty subjects in total will be enrolled at Weill Cornell Medical College (WCMC)/ NYPH. The primary objective is to evaluate the ability of 89Zr-Df-IAB2M to detect localized, clinically significant (defined as: ≥ 0.5 cm3 with Gleason pattern ≥ 4) prostate cancer (PCa). After the screening period (up to 28 days), each subject will be scheduled to receive 10 mg infusion of IAB2M conjugated with 2.5 mCi 89Zr-Df. 2 - 4 days post-infusion, subjects will undergo a 89Zr-Df-IAB2M PET/CT scan. Images read by a Nuc Med MD reporting: location, SUV and, if possible, size of all areas with abnormal uptake. (they will also undergo a pelvic MRI if they have not obtained an MR image during the screening period or on day of infusion) Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance. Patient will undergo radical prostatectomy after completion of above imaging procedures.

Conditions Studied

Interventions

  • DRUG 68Ga-PSMA-HBED-CC
  • DRUG 89ZR-DF-IAB2M

Study Locations (1)

New York

  • Weill Cornell Medicine - New York

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2017-02-08
Est. Completion 2018-06-27
Phase Phase 2

What the Registry Record Tells You About NCT03675451

The ClinicalTrials.gov registry entry for NCT03675451 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which 68Ga-PSMA-HBED-CC is the first listed.

NCT03675451 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT03675451 about?

NCT03675451 is a clinical study titled "PSMA Imaging of Localized Prostate Cancer". The present study is a phase II, open label, single-center, non-randomized, single-dose study. Twenty subjects in total will be enrolled at Weill Cornell Medical College (WCMC)/ NYPH. The primary objective is to evaluate the ability of 89Zr-Df-IAB2M to detect localized, clinically significant (def...

What is the current status of trial NCT03675451?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2017-02-08. Estimated completion is 2018-06-27.

What conditions does trial NCT03675451 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT03675451?

The interventions under investigation include: 68Ga-PSMA-HBED-CC (DRUG), 89ZR-DF-IAB2M (DRUG).

Who is sponsoring clinical trial NCT03675451?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03675451 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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