Imaging solid tumors with a new radiolabeled agent
Imaging of Solid Tumors Using FAP-2286
This study is testing a new imaging agent to see if it can better detect metastatic cancer in patients with solid tumors compared to standard imaging methods.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 191 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT04621435 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histopathologically confirmed solid tumors, particularly those with metastatic disease or high-risk disease without evidence of metastasis.
Not a fit: Patients with non-solid tumors or those who do not meet the eligibility criteria, such as those under 18 years old, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate method for detecting metastatic cancer, potentially leading to better treatment planning and outcomes for patients.
How similar studies have performed: Other studies have shown promise in using similar imaging approaches, but the specific application of FAP-2286 is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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, or colon cancer. ii. Pathologically confirmed cancer other than noted above (basket subgroup, n=10). 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 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. 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 this trial is running
San Francisco, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.