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Recruiting Phase 1 NCT05562791

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

Phase 1 – testing safety in a small group of people
Conditions: Bladder Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

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Overview
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
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.
Interventions
[68Ga]PSMA
DRUG
PET/CT imaging
DIAGNOSTIC_TEST
Locations 7
United States (7)
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge , New Jersey
Gopakumar Iyer, MD
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack , New York
Gopakumar Iyer, MD
Memorial Sloan Kettering West Harrison (All Protocol Activities)
Harrison , New York
Gopakumar Iyer, MD
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown , New Jersey
Gopakumar Iyer, MD
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale , New Jersey
Gopakumar Iyer, MD
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York , New York
Gopakumar Iyer, MD
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale , New York
Gopakumar Iyer, MD
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
28.09.2022
Completion date
01.09.2027
Registry ID
NCT05562791
Source
clinicaltrials.gov
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