68 Gallium-Fibroblast Activating Protein Inhibitors-46 Positron Emission Tomography - Computerized Tomography for Molecular Assessment of Fibroblast Activation and Risk Assessment in Solid Tumors

Last updated: June 3, 2024
Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

68 Gallium -Fibroblast Activating Protein Inhibitor -46 Positron emission tomography / Computerized tomography

Clinical Study ID

NCT06136065
IRST 100.59
2024-511659-17-00
2022-003786-38
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 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;

  2. 18-Fluorine-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose Positron emissiontomography / Computerized tomography or other clinical practice morpho-functionalimaging 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 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.

  6. Participant is willing and able to give informed consent for participation in thestudy.

Exclusion

Exclusion Criteria:

  1. Participation in another clinical trial with any investigational agents within 30days prior to study entry or 5 half lives of the study drug.

  2. Medical or psychological conditions that would not allow the participant tounderstand, or sign the informed consent

  3. History of allergic reactions attributed to compounds of similar chemical orbiologic composition to Fibroblast Activating Protein Inhibitor or other agents usedin 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 > 2.5respect to upper normal limits)

  9. Pregnancy and lactation

  10. Subject deprived of its freedom by administrative or legal decision or who is underguardianship

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: 68 Gallium -Fibroblast Activating Protein Inhibitor -46 Positron emission tomography / Computerized tomography
Phase: 2
Study Start date:
August 21, 2023
Estimated Completion Date:
September 30, 2025

Study 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 the "tumor microenvironment". In particular, a subpopulation of fibroblasts called cancer-associated fibroblasts are involved in tumor growth, migration and progression. Therefore, these cells represent an attractive target for both diagnosis and anticancer therapy.

A distinctive feature of cancer-associated fibroblasts is the expression of the fibroblast activating protein, a type II membrane-bound glycoprotein. Fibroblast Activating Protein plays a role in normal developmental processes during embryogenesis and in tissues modeling.

The presence of Fibroblast Activating Protein in cancer-associated fibroblasts in many solid tumors and the fact that overexpression is associated with a worse prognosis in cancer patients has led to the hypothesis that Fibroblast Activating Protein plays a fundamental role in the development of cancer, in the migration of cancer cells, and in the spread of cancer. Therefore, the targeting of this enzyme for imaging and endo-radiotherapy can be seen as a promising strategy for detecting and treating malignant tumors.

Connect with a study center

  • IRCCS Istituto ROmagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.

    Meldola, Forlì Cesena 47014
    Italy

    Active - Recruiting

  • Azienda USL Toscana Centro - SOC Medicina Nucleare - Nuovo Ospedale "Santo Stefano"

    Prato, 59100
    Italy

    Site Not Available

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