A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer (NCT05562791) | Clinical Trial Compass
RecruitingPhase 1
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
United States20 participantsStarted 2022-09-28
Plain-language 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 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 participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 superf…
What they're measuring
1
Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma
Timeframe: 1 year
2
Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma