Clinical trial NCT05562791: A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
Official title: Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Bladder Cancer
Keywords: Metastatic
Urothelial carcinoma
68Gallium
PSMA-PET/CT
22-157
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
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

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 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.

Primary outcomes:
measure: Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma
timeFrame: 1 year
measure: Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Gopakumar Iyer
role: PRINCIPAL_INVESTIGATOR
References: