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

Solid Tumor, Unspecified, Adult Clinical Trial

— FAPI  

Official title:

68Ga-FAPI-46 Positron Emission Tomography - Computerized Tomography for Molecular Assessment of Fibroblast Activation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136065
• Other study ID #: IRST 100.59
• Secondary ID: 2022-003786-3820
• Status: Recruiting
• Phase: Phase 2
• Start date: August 21, 2023
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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;

2. 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;

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 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.

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

Exclusion Criteria:

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

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 Fibroblast Activating Protein Inhibitor or other agents used in 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 > 2.5 respect to upper normal limits)

9. Pregnancy and lactation

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

Related Conditions & MeSH terms

• Solid Tumor, Unspecified, Adult

Intervention

Diagnostic Test:
• 68 Gallium -Fibroblast Activating Protein Inhibitor -46 Positron emission tomography / Computerized tomography
68 Gallium -Fibroblast Activating Protein Inhibitor -46 Positron emission tomography / Computerized tomography scan

Locations

Country	Name	City	State
Italy	IRCCS Istituto ROmagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.	Meldola	Forlì Cesena
Italy	Azienda USL Toscana Centro - SOC Medicina Nucleare - Nuovo Ospedale "Santo Stefano"	Prato

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of 68-Gallium -Fibroblast Activating Protein Inhibitor - 46 Positron emission tomography / Computerized tomography	ratio between the number of 68 Gallium - Fibroblast Activating Protein Inhibitor -46 Positron emission tomography / Computerized tomography positive patients and the number of patients with solid tumors presenting with Fluorodeoxyglucose Positron Emission Tomography/Computerized Tomography scan or other clinical practice morpho-functional imaging dubious or inconclusive.	30 months
Secondary	Detection rate of lesions, stratified by tumor histology	Proportion of positive patients on total number who underwent 68 Gallium -Fibroblast Activating Protein Inhibitor -46 Positron emission tomography / Computerized tomography stratified for tumor histotypes	30 months
Secondary	Detection rate of stratified lesions for different lesion sites	Proportion of positive patients on total number who underwent 68 Gallium -Fibroblast Activating Protein Inhibitor -46 Positron emission tomography / Computerized tomography stratified for different lesion sites	30 months
Secondary	Uptake of 68 Gallium -Fibroblast Activating Protein Inhibitor -46	Uptake of 68 Gallium - Fibroblast Activating Protein Inhibitor - 46 in terms of SUV	30 months
Secondary	Safety (percentage of patients)	safety is defined as the percentage of treated patients undergoing grade 1 to 4 adverse events	30 months