Imaging solid tumors with a new radiolabeled agent

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a novel imaging agent, FAP-2286, labeled with either gallium-68 or copper-64, to detect metastatic cancer in patients with solid tumors. The study is multi-arm and focuses on various types of cancers, including breast, pancreatic, sarcoma, prostate, bladder, colon, and head and neck cancers. It aims to assess the safety, dosimetry, and feasibility of using FAP-2286 for imaging, comparing its effectiveness to conventional imaging methods. Participants will undergo PET imaging to evaluate tumor uptake and retention of the radiotracer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \>= 18 years.
2. Histopathologically confirmed solid tumors in one of the following cohorts:

   a. Cohort 1 (n=11): measurable disease is not required for this cohort.

   i. Agnostic to tumor type.

   b. Cohort 2 (n=95): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study.

   i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, colon cancer, or other cancer type.

   c. Cohort 3 (n=85): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study.

   i. Participants 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. Participants may also be imaged after 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, bladder cancer, or other cancer type.
3. Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

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

Where it's running

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

Study contacts

• Principal investigator: Thomas Hope, MD — University of California, San Francisco
• Study coordinator: Maya Aslam
• Email: Maya.Aslam@ucsf.edu
• Phone: 877-827-3222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.