A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
NCT ID: NCT05562791
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2022-09-28
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
[68Ga]PSMA
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
PET/CT imaging
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
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).
[68Ga]PSMA
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
PET/CT imaging
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
Interventions
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[68Ga]PSMA
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
PET/CT imaging
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
Eligibility Criteria
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Inclusion Criteria
* At least 3 lesions 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
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gopakumar Iyer
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Alexander Shoushtari, MD
Role: CONTACT
Phone: 646-888-4161
Facility Contacts
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Gopakumar Iyer, MD
Role: primary
Alexander Shoushtar, MD
Role: backup
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-157
Identifier Type: -
Identifier Source: org_study_id