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68Ga PSMA-PET/CT Scan for Bladder Cancer

Phase 1

Recruiting

Led By Gopakumar Iyer

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with histologically confirmed metastatic urothelial carcinoma with extrapelvic nodal and/or visceral sites of disease (including lung, liver, bone, or soft tissue)

Karnofsky performance status ≥50% (or ECOG/WHO ≤2)

Must not have

Unable to lie flat, still, or to tolerate a PET scan

Patients with bone only disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a 68Gallium PSMA PET/CT scan can better detect cancer in people with metastatic bladder cancer than the standard FDG-PET/CT scan.

Who is the study for?

This trial is for adults with metastatic bladder cancer, specifically urothelial carcinoma that has spread beyond the pelvis. Participants must have at least three lesions visible on standard PET/CT scans and be in a condition where they can perform daily activities (Karnofsky performance status ≥50%). Pregnant women, patients on other clinical trials or those with only bone disease are excluded.

What is being tested?

The study is testing if 68Gallium PSMA-PET/CT scans are more effective than the usual FDG-PET/CT scans for detecting cancer sites in people with metastatic bladder cancer. It aims to determine whether this new type of scan provides better imaging results.

What are the potential side effects?

While specific side effects aren't detailed here, typical risks may include discomfort during the scan, potential allergic reactions to tracers used in PET/CT imaging, and exposure to radiation which carries a small risk of causing future cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread beyond the pelvic area to organs like the lung, liver, or bones.

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I can do most of my daily activities by myself.

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I am 18 years old or older.

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I have at least 3 lesions suspected of spreading, confirmed by a specialist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot stay still or lie flat for a PET scan.

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My cancer is only in my bones.

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I am being treated for a cancer that is not urothelial, except for non-spreading skin cancers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma

Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients with metastatic urothelial carcinoma lesionsExperimental Treatment2 Interventions

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

Group II: Patients with melanoma lesionsExperimental Treatment2 Interventions

Patients with melanoma who have 1 or more radiographically assessable metastatic lesions on standard of care imaging will undergo a 68Gallium PSMA-PET/CT and standard of care imaging (either FDG PET or CT scan).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

[68Ga]PSMA

2022

N/A

~40

PET/CT imaging

2021

Completed Phase 3

~430