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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Enrolling; Phase 1

Conditions: Bladder Cancer

Treatments: Drug: [68Ga]PSMA; Diagnostic Test: PET/CT imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT05562791

22-157

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Patients with metastatic urothelial carcinoma lesions

Experimental group

Description:

Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.

Treatment:

Diagnostic Test: PET/CT imaging

Drug: [68Ga]PSMA

Patients with melanoma lesions

Experimental group

Description:

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).

Treatment:

Diagnostic Test: PET/CT imaging

Drug: [68Ga]PSMA