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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05562791
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [68Ga]PSMA — DRUG
    68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
  • PET/CT imaging — DIAGNOSTIC_TEST
    68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

Study Details

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).

Key Dates

Start date
Sep 28, 2022
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Patients with metastatic urothelial carcinoma lesions
    Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.
  • Experimental: Patients with melanoma lesions
    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).

Primary Outcome Measure

Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Consent Only)Basking RidgeNew Jersey10065
Gopakumar Iyer, MD
646-888-4737
Memorial Sloan Kettering Monmouth (All Protocol Activities)MiddletownNew Jersey07748
Gopakumar Iyer, MD
646-888-4737
Memorial Sloan Kettering Bergen (All Protocol Activities)MontvaleNew Jersey07645
Gopakumar Iyer, MD
646-888-4737
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)CommackNew York11725
Gopakumar Iyer, MD
646-888-4737
Memorial Sloan Kettering West Harrison (All Protocol Activities)HarrisonNew York10604
Gopakumar Iyer, MD
646-888-4737
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Gopakumar Iyer, MD
646-888-4737
Alexander Shoushtar, MD
646-888-4161
Gopakumar Iyer, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (All Protocol Activities)UniondaleNew York11553
Gopakumar Iyer, MD
646-888-4737

Find similar trials in Basking Ridge, NJ

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Memorial Sloan Kettering Basking Ridge (Consent Only)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (All Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (All Protocol Activities)· Montvale, NJMemorial Sloan Kettering Suffolk - Commack (All Protocol Activities)· Commack, NYMemorial Sloan Kettering West Harrison (All Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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