Using a special imaging technique to assess fibroblast activation in solid tumors
68Ga-FAPI-46 Positron Emission Tomography - Computerized Tomography for Molecular Assessment of Fibroblast Activation
This study is testing a special imaging technique to see if it can help find and understand how certain cells in solid tumors affect cancer growth in patients.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS Academic / other |
| Locations | 2 sites (Meldola, Forlì Cesena and 1 other locations) |
| Trial ID | NCT06136065 on ClinicalTrials.gov |
What this trial studies
This Phase II, open-label, single-arm trial aims to evaluate the presence of Fibroblast Activating Protein (FAP) in patients with solid tumors. The study focuses on understanding how cancer-associated fibroblasts contribute to tumor growth and progression, utilizing 68 Gallium-FAP inhibitors for imaging purposes. By targeting FAP, the trial seeks to improve diagnostic accuracy and potentially enhance treatment strategies for solid tumors. Participants will undergo positron emission tomography and computerized tomography to assess fibroblast activation.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically or cytologically confirmed solid tumors at any stage.
Not a fit: Patients with non-solid tumors or those unable to undergo imaging due to technical reasons may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better diagnostic tools and targeted therapies for patients with solid tumors.
How similar studies have performed: While targeting fibroblast activation is a promising approach, this specific application of 68 Gallium-FAP inhibitors is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients must have histologically or cytologically solid tumors at any stage, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion; 2. 18-Fluorine-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose Positron emission tomography / Computerized tomography or other clinical practice morpho-functional imaging scan dubious or inconclusive; 3. Male or Female, aged\>18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (see Appendix A) 5. A female participant is eligible to participate if she is not pregnant and not breastfeeding. If female of childbearing potential highly effective birth control methods, according to guideline "Recommendation related to contraception and pregnancy testing in clinical trials", (See Appendix D) are mandatory. Highly effective birth control methods are required beginning at the screening visit and continuing at least 6 months following last treatment with study drug. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 6 months after final study drug administration. Two acceptable methods of birth control thus include Condom (barrier method of contraception) and one of the following is required ( established use of oral, or injected or implanted hormonal method of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier method like occlusive cap with spermicidal foam/gel/film/cream/suppository in the female partner; tubal ligation in the female partner; vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months. 6. Participant is willing and able to give informed consent for participation in the study. Exclusion Criteria: 1. Participation in another clinical trial with any investigational agents within 30 days prior to study entry or 5 half lives of the study drug. 2. Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Fibroblast Activating Protein Inhibitor or other agents used in the study. 4. Inability to remain still for the entire duration of the exam 5. Life expectancy \< 6 months 6. Eastern Cooperative Oncology Group (ECOG) performance status \> 2 7. Patient with compromised renal function (Creatinine\> 2 mg/ml) 8. Patient with altered hepatic function (AST and Alanine Aminotransferase \> 2.5 respect to upper normal limits) 9. Pregnancy and lactation 10. Subject deprived of its freedom by administrative or legal decision or who is under guardianship
Where this trial is running
Meldola, Forlì Cesena and 1 other locations
- IRCCS Istituto ROmagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l. — Meldola, Forlì Cesena, Italy (Recruiting)
- Azienda USL Toscana Centro - SOC Medicina Nucleare - Nuovo Ospedale "Santo Stefano" — Prato, Italy (Active_not_recruiting)
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.