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New treatment option for Bladder Cancer
Official title A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer
ClinicalTrials.gov ID: NCT05562791
What this study is testing
What is [68Ga]PSMA?
[68Ga]PSMA is an investigational medicine, being studied as a potential treatment for bladder cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for Urothelial Carcinoma Cohort:
- Patients with histologically confirmed metastatic urothelial carcinoma with extrapelvic nodal and/or visceral sites of disease (including lung...
- At least 1 lesion assessable by FDG PET/CT according to RECIST and PERCIST guidelines where applicable, that are determined suspicious for metastasis...
- Karnofsky performance status ≥50% (or ECOG/WHO ≤2)
- Participant is ≥18 years of age
You likely can't join if
- 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...
- 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...
- Patients on a therapeutic clinical trial where PSMA imaging would interfere with the conduct of the trial
See the full eligibility 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 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.