A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
Recruiting · NCT05562791 · Interventional (participants receive a specific treatment) · Lead sponsor: Memorial Sloan Kettering Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
PET/CT imaging[68Ga]PSMA
What this trial is about
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 or skin 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 or skin cancer (FDG-PET/CT scan).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- for Urothelial Carcinoma Cohort:
- 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 1 lesion 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
- Inclusion Criteria for Melanoma Cohort:
- Patients with histologically confirmed metastatic melanoma
- At least 1 metastatic lesion assessable by CT or FDG PET/CT according to RECIST that is determined to be suspicious for metastasis by an MSKCC attending radiologist or nuclear medicine physician
- ECOG \<= 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
- for Urothelial Carcinoma Cohort:
- 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 where PSMA imaging would interfere with the conduct of the 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.
- Exclusion Criteria for Melanoma Cohort:
- Unable to lie flat, still, or tolerate PET scan.
- Patient is on another therapeutic trial where PSMA imaging would interfere with the conduct of the trial.
- Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test.
Where it is running
7 locations listed across 2 US states.
- Memorial Sloan Kettering Basking Ridge (Consent Only) - Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth (All Protocol Activities) - Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen (All Protocol Activities) - Montvale, New Jersey, United States
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) - Commack, New York, United States
- Memorial Sloan Kettering West Harrison (All Protocol Activities) - Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York, New York, United States
- Memorial Sloan Kettering Nassau (All Protocol Activities) - Uniondale, New York, United States