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NCT07635524 · ClinicalTrials.gov registry record · Phase 2

A Phase 2 Trial of 61Cu-NU101 PET/CT Compared Against Current Standard-of-care 18F-piflufolastat (Pylarify®) PET/CT.

A Phase 2 study, sponsored by Hoag Memorial Hospital Presbyterian.

Not yet
Registry status
Phase 2
Development phase
34
Enrollment target

NCT07635524: Clinical Trial Phase 2 study, sponsored by Hoag Memorial Hospital Presbyterian.

NCT07635524 is a Phase 2 study that has not yet begun recruiting, run by Hoag Memorial Hospital Presbyterian. The registered enrollment target is 34 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07635524, a Phase 2 study, has not yet begun recruiting, sponsored by Hoag Memorial Hospital Presbyterian.

NOT YET RECRUITING
Registry status
Phase 2
Development phase
34 participants
Enrollment target

Study Summary

The purpose of this research is to test whether a new investigational Molecular Imaging (MI) agent called 61Cu-NU101 is equal to or better than a currently used MI agent, Pylarify, for the detection of prostate cancer metastases. 34 participants with biopsy-proven prostate cancer and cancer seen on a Pylarify PET scan will be enrolled in this study. The investigational 61Cu-NU101 PET/CT will be perfromed. If there is a difference between the standard Pylarify exam and the investigational 61Cu-NU101 exam, a biopsy of one lesion that is different between the two exams may be performed.

Primary Outcome

Demonstrate the sensitivity of imaging with 61Cu- NU101, as compared to a currently standard of care PSMA-targeted imaging agent, 18F-piflufolastat.

Interventions

  • DRUG Cu-NU101

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2026-08-01
Est. Completion 2028-10-01
Phase Phase 2

What is known before NCT07635524 opens enrollment

NCT07635524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 1 intervention - of which Cu-NU101 is the first listed.

NCT07635524 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07635524 about?

NCT07635524 is a clinical study titled "A Phase 2 Trial of 61Cu-NU101 PET/CT Compared Against Current Standard-of-care 18F-piflufolastat (Pylarify®) PET/CT.". The purpose of this research is to test whether a new investigational Molecular Imaging (MI) agent called 61Cu-NU101 is equal to or better than a currently used MI agent, Pylarify, for the detection of prostate cancer metastases. 34 participants with biopsy-proven prostate cancer and cancer seen on...

What is the current status of trial NCT07635524?

This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2026-08-01. Estimated completion is 2028-10-01.

What interventions are being tested in trial NCT07635524?

The interventions under investigation include: Cu-NU101 (DRUG).

Who is sponsoring clinical trial NCT07635524?

This trial is sponsored by Hoag Memorial Hospital Presbyterian, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07635524's enrollment target sits among peer trials

34 1539th of 2000 higher than 448 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 NCT07635524, the US trial registry maintained by the National Library of Medicine. NCT07635524 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.