68Ga-FAPI-46 PET-CT for molecular assessment of fibroblast activation and risk assessment in solid tumors (FAPI Basket)

Phase 1

Recruiting

• Conditions: Solid tumors; MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-511659-17-00
• Lead Sponsor: Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-29
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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, 18F-FDG PET/CT scan or other clinical practice morpho-functional imaging dubious or inconclusive., Male or Female, aged=18 years, ECOG performance status =2, 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; IRST100.59 - FAPI BASKET Page 16 of 35 Prot_v3.1_14.01.24 vasectomy or other procedure resulting in infertility (eg., bilateral orchiectomy), for more than 6 months., Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria

Participation in another clinical trial with any investigational agents within 30 days prior to study entry or 5 hemivitae of the study drug, Subject deprived of its freedom by administrative or legal decision or who is under guardianship, Medical or psychological conditions that would not allow the participant to understand, or sign the informed consent, History of allergic reactions attributed to compounds of similar chemical or biologic composition to FAPI or other agents used in the study., Inability to remain still for the entire duration of the exam, Life expectancy < 6 months, ECOG performance status > 2, Patient with compromised renal function (Creatinine> 2 mg/ml), Patient with altered hepatic function (AST and ALT > 2.5 respect to upper normal limits), Pregnancy and lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified