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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
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 belowSelect...
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:Select...
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
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
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
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,536 Total Patients Enrolled
Gopakumar IyerPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot stay still or lie flat for a PET scan.My cancer has spread beyond the pelvic area to organs like the lung, liver, or bones.You are currently participating in another medical treatment study.I am being closely monitored for cancer that is not urothelial cancer.I can do most of my daily activities by myself.I am 18 years old or older.My cancer has spread to lymph nodes outside my pelvis.My cancer is only in my bones.I have at least 3 lesions suspected of spreading, confirmed by a specialist.I am being treated for a cancer that is not urothelial, except for non-spreading skin cancers.
Research Study Groups:
This trial has the following groups:- Group 1: Patients with melanoma lesions
- Group 2: Patients with metastatic urothelial carcinoma lesions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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