Imaging of Solid Tumors Using FAP-2286

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    80
  • sponsor
    Thomas Hope
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Updated on 4 October 2022
See if I qualify
cancer
measurable disease
breast cancer
colon cancer
bone metastases
adenocarcinoma

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.

Description

Initially the investigator(s) will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer.

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.

Details
Condition Solid Tumors, Adult, Metastatic Cancer
Treatment Positron emission tomography (PET) imaging, Gallium-68 labelled (68Ga-) FAP-2286
Clinical Study IdentifierNCT04621435
SponsorThomas Hope
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age >= 18 years
Histopathologically confirmed solid tumors in one of the following cohorts
Cohort 1 (n=10): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases
Agnostic to tumor type. b. Cohort 2 (n=40): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases
Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, or colon cancer
ii. Pathologically confirmed cancer other than noted above (basket subgroup
n=10)
c. Cohort 3 (n=30): No evidence of metastatic disease as defined as the absence of
ii. Pathologically confirmed head and neck cancer or bladder cancer
Ability to understand a written informed consent document, and the willingness to sign
RECIST 1.1 measurable disease or bone metastases
it
i. 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

Exclusion Criteria

Unlikely to comply with protocol procedures, restrictions and requirements and judged
by the Investigator to be unsuitable for participation
Known pregnancy
Clear my responses
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