Phase
Condition
N/ATreatment
68 Gallium -Fibroblast Activating Protein Inhibitor -46 Positron emission tomography / Computerized tomography
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients must have histologically or cytologically solid tumors at any stage, ifbiopsy is no feasible for technical reason or risk benefit balance, patients may beenrolled if CT or MRI strongly suggest oncological lesion;
18-Fluorine-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose Positron emissiontomography / Computerized tomography or other clinical practice morpho-functionalimaging 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 notbreastfeeding. If female of childbearing potential highly effective birth controlmethods, according to guideline "Recommendation related to contraception andpregnancy testing in clinical trials", (See Appendix D) are mandatory. Highlyeffective birth control methods are required beginning at the screening visit andcontinuing at least 6 months following last treatment with study drug. Male patientand his female partner who is of childbearing potential must use 2 acceptablemethods of birth control (1 of which must include a condom as a barrier method ofcontraception) starting at screening and continuing throughout the study period andfor 6 months after final study drug administration. Two acceptable methods of birthcontrol thus include Condom (barrier method of contraception) and one of thefollowing is required ( established use of oral, or injected or implanted hormonalmethod of contraception by the female partner; placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner; additional barrier methodlike occlusive cap with spermicidal foam/gel/film/cream/suppository in the femalepartner; tubal ligation in the female partner; vasectomy or other procedureresulting in infertility (eg., bilateral orchiectomy), for more than 6 months.
Participant is willing and able to give informed consent for participation in thestudy.
Exclusion
Exclusion Criteria:
Participation in another clinical trial with any investigational agents within 30days prior to study entry or 5 half lives of the study drug.
Medical or psychological conditions that would not allow the participant tounderstand, or sign the informed consent
History of allergic reactions attributed to compounds of similar chemical orbiologic composition to Fibroblast Activating Protein Inhibitor or other agents usedin 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 > 2.5respect to upper normal limits)
Pregnancy and lactation
Subject deprived of its freedom by administrative or legal decision or who is underguardianship
Study Design
Study Description
Connect with a study center
IRCCS Istituto ROmagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.
Meldola, Forlì Cesena 47014
ItalyActive - Recruiting
Azienda USL Toscana Centro - SOC Medicina Nucleare - Nuovo Ospedale "Santo Stefano"
Prato, 59100
ItalySite Not Available
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