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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05562791
• Other study ID #: 22-157
• Status: Recruiting
• Phase: Phase 1
• Start date: September 28, 2022
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Gopakumar Iyer, MD
• Phone: 646-888-4737
• Email: iyerg[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center