NCT05562791 A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
| NCT ID | NCT05562791 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-09-28 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2022-09-28 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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.
Contact & Investigator
Gopakumar Iyer
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05562791 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05562791 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05562791 currently recruiting?
Yes, NCT05562791 is actively recruiting participants. Contact the research team at iyerg@mskcc.org for enrollment information.
Where is the NCT05562791 trial being conducted?
This trial is being conducted at Basking Ridge, United States, Middletown, United States, Montvale, United States, Commack, United States and 3 additional locations.
Who is sponsoring the NCT05562791 clinical trial?
NCT05562791 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Gopakumar Iyer at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 20 participants.
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