Status:
UNKNOWN
68 Gallium-Fibroblast Activating Protein Inhibitors-46 Positron Emission Tomography - Computerized Tomography for Molecular Assessment of Fibroblast Activation and Risk Assessment in Solid Tumors
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Solid Tumor, Unspecified, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Phase II, open label, single arm, single center, prospective diagnostic trial to evaluate the Fibroblast Activating Protein (FAP) positivity in patients with solid tumors
Detailed Description
The growth and spread of the tumor is determined not only by the tumor cells but also by the non-malignant constituents of the malignant lesion, which contributes to what is commonly referred to as th...
Eligibility Criteria
Inclusion
- 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;
- 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;
- Male or Female, aged\>18 years
- Eastern Cooperative Oncology Group (ECOG) performance status \<2 (see Appendix A)
- 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.
- Participant is willing and able to give informed consent for participation in the study.
Exclusion
- Participation in another clinical trial with any investigational agents within 30 days prior to study entry or 5 half lives of the study drug.
- 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 Fibroblast Activating Protein Inhibitor or other agents used in the study.
- Inability to remain still for the entire duration of the exam
- Life expectancy \< 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
- Patient with compromised renal function (Creatinine\> 2 mg/ml)
- Patient with altered hepatic function (AST and Alanine Aminotransferase \> 2.5 respect to upper normal limits)
- Pregnancy and lactation
- Subject deprived of its freedom by administrative or legal decision or who is under guardianship
Key Trial Info
Start Date :
August 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06136065
Start Date
August 21 2023
End Date
September 1 2025
Last Update
June 4 2024
Active Locations (2)
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1
IRCCS Istituto ROmagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.
Meldola, Forlì Cesena, Italy, 47014
2
Azienda USL Toscana Centro - SOC Medicina Nucleare - Nuovo Ospedale "Santo Stefano"
Prato, Italy, 59100