A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05562791

Collaborator

(none)

Enrollment

Location

Arm

23.1

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see whether 68Gallium PSMA-PET/CT scans are an effective way to detect sites of cancer in people with metastatic bladder cancer. The study researchers want to learn if a 68Gallium PSMA PET/CT scan will work better, the same, or not as well as the PET/CT scans doctors usually use for imaging bladder cancer (FDG-PET/CT scan).

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Drug: [68Ga]PSMA Diagnostic Test: PET/CT imaging	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a prospective, single-arm pilot study of 68Gallium PSMA-PET/CT imaging in patients with metastatic urothelial carcinoma.This is a prospective, single-arm pilot study of 68Gallium PSMA-PET/CT imaging in patients with metastatic urothelial carcinoma.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma

Actual Study Start Date :

Sep 28, 2022

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 68Gallium PSMA-PET/CT Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.	Drug: [68Ga]PSMA 68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT. Diagnostic Test: PET/CT imaging 68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

Arm

Intervention/Treatment

Experimental: 68Gallium PSMA-PET/CT

Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.

Drug: [68Ga]PSMA

68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

Diagnostic Test: PET/CT imaging

68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

Outcome Measures

Primary Outcome Measures

Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT [1 year]
If 6 of 10 patients have at least one lesion identified both on standard of care FDG PET/CT and also detected on 68Gallium PSMA-PET/CT, this imaging modality will be worthy of further exploration in metastatic UC.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with histologically confirmed metastatic urothelial carcinoma with extrapelvic nodal and/or visceral sites of disease (including lung, liver, bone, or soft tissue)
At least 3 lesions assessable by FDG PET/CT according to RECIST and PERCIST guidelines where applicable, that are determined suspicious for metastasis by an MSKCC attending radiologist or nuclear medicine physician.
Karnofsky performance status ≥50% (or ECOG/WHO ≤2)
Participant is ≥18 years of age
Patient must be able to understand and is willing to sign a written informed consent document

Exclusion Criteria:

Patients with pelvic node-only metastatic disease. If the patient has lymph node only disease, at least one PET-assessable node must be located outside of the pelvis
Patients with bone only disease
Unable to lie flat, still, or to tolerate a PET scan
Patient undergoing active treatment for non-urothelial malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized.
Patients on a therapeutic clinical trial
Patients undergoing active surveillance with a known history of non-urothelial malignancies
Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test.