Diagnostic PET/CT (Positron Emission Tomography/Computed Tomography) examination with the radiotracer 68Ga-FAPI-46 to assess fibroblast activation and risk in solid tumors

Phase 1

• Conditions: Solid tumors; MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-003786-38-IT
• Lead Sponsor: ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-29
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Patients must have histologically or cytologically solid tumors at any stage
2.18F-FDG PET/CT scan dubious or inconclusive
3.Male or Female, aged>18 years
4.ECOG performance status <2
5.If female of childbearing potential highly effective birth control methods, according to guideline Recommendation related to contraception and pregnancy testing in clinical trials”, (2014_09_15 section 4.1) 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. Negative serum pregnancy test for females of childbearing potential within 14 days of starting treatment. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Participation in another clinical trial with any investigational agents within 30 days prior to study entry.
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 FAPI or other agents used in the study.
4.Inability to remain still for the entire duration of the exam
5.Pregnancy and lactation

Study & Design

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