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

Primary Purpose

Bladder Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[68Ga]PSMA
PET/CT imaging
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bladder Cancer focused on measuring Metastatic, Urothelial carcinoma, 68Gallium, PSMA-PET/CT, 22-157

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Memorial Sloan Kettering Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Gallium PSMA-PET/CT

Arm Description

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

Outcomes

Primary Outcome Measures

Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT
If 6 of 10 patients have at least one lesion identified both on standard of care FDG PET/CT and also detected on 68Gallium PSMA-PET/CT, this imaging modality will be worthy of further exploration in metastatic UC.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2022
Last Updated
September 28, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT05562791
Brief Title
A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer
Official Title
Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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. 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 (FDG-PET/CT scan).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Metastatic, Urothelial carcinoma, 68Gallium, PSMA-PET/CT, 22-157

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, single-arm pilot study of 68Gallium PSMA-PET/CT imaging in patients with metastatic urothelial carcinoma.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Gallium PSMA-PET/CT
Arm Type
Experimental
Arm Description
Patients will initially undergo a standard of care FDG PET with diagnostic CT scan followed by an investigational 68Ga PSMA PET/CT scan.
Intervention Type
Drug
Intervention Name(s)
[68Ga]PSMA
Intervention Description
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT imaging
Intervention Description
68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
Primary Outcome Measure Information:
Title
Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT
Description
If 6 of 10 patients have at least one lesion identified both on standard of care FDG PET/CT and also detected on 68Gallium PSMA-PET/CT, this imaging modality will be worthy of further exploration in metastatic UC.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gopakumar Iyer, MD
Phone
646-888-4737
Email
iyerg@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Morris, MD
Phone
646-422-4469
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gopakumar Iyer
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gopakumar Iyer, MD
Phone
646-888-4737
First Name & Middle Initial & Last Name & Degree
Michael Morris, MD
Phone
646-422-4469
First Name & Middle Initial & Last Name & Degree
Gopakumar Iyer, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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

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