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Trial Title:
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
NCT ID:
NCT05562791
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
Metastatic
Urothelial carcinoma
68Gallium
PSMA-PET/CT
22-157
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention model description:
This is a prospective, single-arm pilot study of 68Gallium PSMA-PET/CT imaging in
patients with metastatic urothelial carcinoma or Melanoma.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[68Ga]PSMA
Description:
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
Arm group label:
Patients with melanoma lesions
Arm group label:
Patients with metastatic urothelial carcinoma lesions
Intervention type:
Diagnostic Test
Intervention name:
PET/CT imaging
Description:
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
Arm group label:
Patients with melanoma lesions
Arm group label:
Patients with metastatic urothelial carcinoma lesions
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).
Criteria for eligibility:
Criteria:
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 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
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gopakumar Iyer, MD
Phone:
646-888-4737
Contact backup:
Last name:
Alexander Shoushtar, MD
Phone:
646-888-4161
Investigator:
Last name:
Gopakumar Iyer, MD
Email:
Principal Investigator
Start date:
September 28, 2022
Completion date:
September 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05562791
http://www.mskcc.org/mskcc/html/44.cfm
