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

NCT06136065 | Unknown Phase 2

• 3 other identifiers: IRST 100.592022-003786-382024-511659-17-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Conditions

Solid Tumor, Unspecified, Adult

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Detection rate of lesions, stratified by tumor histology

  30 months

• Detection rate of stratified lesions for different lesion sites

  30 months

• Uptake of 68 Gallium -Fibroblast Activating Protein Inhibitor -46

  30 months

• Safety (percentage of patients)

  30 months

Study Arms (1)

Arm 1

EXPERIMENTAL

100 patients with solid tumor and 18-Fluorine-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose Positron emission tomography / Computerized tomography scan dubious

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

Interventions

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

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

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Study Sites (2)

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

Meldola, Forlì Cesena, 47014, Italy

RECRUITING

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

Prato, 59100, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 100 patients will be enrolled. The proportion of 68-Gallium-Fibroblast Activating Protein Inhibitor-46 Positron Emission Tomography /Computerized Tomography positive patients or lesions will be calculated as well as 95% confidence intervals (CI). Median and ranges or mean and standard deviation, as appropriate, will be used to describe 68-Gallium-Fibroblast Activating Protein Inhibitor-46 (68Ga-FAPI-46) uptake. The number and percentage of treated patients undergoing grade 1 to 4 adverse events will be tabulated according to CTCAE version 5.0.

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: November 18, 2023
• Study Start: August 21, 2023
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 4, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)