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

Part of paid clinical trials in Newport Beach, California.

Sponsor
Hoag Memorial Hospital Presbyterian
Study ID
NCT07635524
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cu-NU101 — DRUG
    Subjects will receive a single dose of 61Cu-NU101, administered as a slow intravenous bolus over 10 seconds, with a dosage of 148 MBq (4 mCi) +/-10% , followed by PET/CT imaging 1 hour (+/- 10 minutes) and 4 hours (+/- 30 minutes) post radiotracer administration. There are no specific restrictions that should apply when administering 61Cu-NU101. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection.

Study Details

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.

Key Dates

Start date
Aug 1, 2026
Status verified
Apr 2026
Primary completion
Aug 1, 2028
Completion
Oct 1, 2028

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cu-NU101
    Subjects will receive a single dose of 61Cu-NU101, administered as a slow intravenous bolus over 10 seconds, with a dosage of 148 MBq (4 mCi) +/-10% , followed by PET/CT imaging 1 hour (+/- 10 minutes) and 4 hours (+/- 30 minutes) post radiotracer administration. There are no specific restrictions that should apply when administering 61Cu-NU101. There will be optional 5-minute dynamic scans at tracer administration and 20- and 40-minutes post injection.

Primary Outcome Measure

Sensitivity of imaging with 61Cu- NU101, [ Time Frame: 4 hours post-administration ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hoag Family Cancer InstituteNewport BeachCalifornia92663
Beth Thomsen, CNMT, CRC
[email protected]
949-557-0285
Gary Ulaner, MD, PhD (PRINCIPAL_INVESTIGATOR)
Washington Univeristy School of MedicineSt LouisMissouri63110
Vikas Prasad

Find similar trials in Newport Beach, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Hoag Family Cancer Institute· Newport Beach, CAWashington Univeristy School of Medicine· St Louis, MO

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