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Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Consent Only)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering West Harrison (All Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITING
Uniondale
Contact Information
Primary
Gopakumar Iyer, MD
iyerg@mskcc.org
646-888-4737
Backup
Alexander Shoushtari, MD
646-888-4161
Time Frame
Start Date: 2022-09-28
Estimated Completion Date: 2027-09
Participants
Target number of participants: 20
Treatments
Experimental: Patients with metastatic urothelial carcinoma lesions
Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.
Experimental: Patients with melanoma lesions
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).
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov