Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Thomas Hope, MD
Photo of Thomas Hope
Thomas Hope

Description

Summary

This is a single arm prospective trial that evaluates the ability of a novel imaging agent gallium-68 labelled (68Ga-) FAP-2286 (68Ga-FAP-2286) to detect metastatic cancer in participants with solid tumors using 68Ga-FAP-2286 tracer. FAP-2286 is a peptidomimetic molecule that that binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on cancer-associated fibroblasts, and has been shown to be present on a number of solid tumors.

Details

Initially we will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer. Using PET imaging we would like to further investigate, 68Ga-FAP-2286 in the following study aims: 1) determine the dosimetry for gallium-68 labelled (68Ga-) FAP-2286, 2) evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286, and 3) evaluate the ability of FAP-2286 to detect metastatic disease. PRIMARY OBJECTIVES 1. All cohorts: Safety of 68Ga-FAP-2286 2. Cohort 1: determine the organ dosimetry of 68Ga-FAP-2286 3. Cohort 2: determine the feasibility of detecting tumor uptake using 68Ga-FAP-2286 4. Cohort 3: determine the feasibility of detecting metastatic disease using 68Ga-FAP-2286 EXPLORATORY OBJECTIVES 1. Correlation of 68Ga-FAP-2286 uptake with FAP expression determined by immunohistochemistry. 2. Compare 68Ga-FAP-2286 scan results to archival Fluorodeoxyglucose (FDG)-PET images. 3. Compare biodistribution of 68Ga-FAP-2286 in normal organs and blood pool based on renal function. 4. Determine impact of administered dose of 68Ga-FAP-2286 on image quality. A repeat 68Ga-FAP-2286 PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Patients will be followed for up to 3 days after the injection of 68Ga-FAP-2286 for evaluation of adverse events.

Keywords

Solid Tumors, Adult Metastatic Cancer PET Neoplasm Metastasis Gallium-68 labelled (68Ga-) FAP-2286 Positron Emission Tomography (PET) imaging

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age >= 18 years
  2. Histopathologically confirmed solid tumors in one of the following cohorts:
  3. Cohort 1 (n=5): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases.
  4. Agnostic to tumor type. b. Cohort 2 (n=30): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases.
  5. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate resistant prostate cancer, bladder cancer, or colon cancer.
  6. Cohort 3 (n=30): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases.
  7. Patients can be imaged at initial staging with what is judged by the treating physician to be high risk disease and where the presence of metastatic disease would greatly impact treatment planning and prognosis. Patients may also be imaged after definitive therapy (surgery, chemotherapy or radiation therapy) if in the determination of the treating physician or investigator there is a high risk of disease recurrence that would also impact treatment plan and/or prognosis.

ii. Pathologically confirmed head and neck cancer or bladder cancer.

  1. Ability to understand a written informed consent document, and the willingness to sign it.

You CAN'T join if...

  1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
  2. Known pregnancy.

Location

  • University of California, San Francisco
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Thomas Hope, MD
    Thomas Hope, MD, is the Director of Molecular Therapy in the Department of Radiology and Biomedical Imaging at the University of California, San Francisco. He serves as Chief of Nuclear Medicine at the San Francisco VA Medical Center. He also serves as chair of the the Cancer Center’s Molecular Imaging & Radionuclide Therapy Site Committee.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Thomas Hope
ID
NCT04621435
Phase
Phase 1
Study Type
Interventional
Last Updated