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Trial Title:
68 Gallium-Fibroblast Activating Protein Inhibitors-46 Positron Emission Tomography - Computerized Tomography for Molecular Assessment of Fibroblast Activation and Risk Assessment in Solid Tumors
NCT ID:
NCT06136065
Condition:
Solid Tumor, Unspecified, Adult
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
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.
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
68 Gallium -Fibroblast Activating Protein Inhibitor -46 Positron emission tomography / Computerized tomography
Description:
68 Gallium -Fibroblast Activating Protein Inhibitor -46 Positron emission tomography /
Computerized tomography scan
Arm group label:
Arm 1
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 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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Istituto ROmagnolo per lo Studio dei Tumori "Dino Amadori"-IRST S.r.l.
Address:
City:
Meldola
Zip:
47014
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Oriana Nanni
Phone:
+390543739266
Email:
oriana.nanni@irst.emr.it
Contact backup:
Last name:
Bernadette Vertogen
Phone:
+390544286058
Email:
bernadette.vertogen@irst.emr.it
Investigator:
Last name:
Paola Caroli, Study Chair
Email:
Principal Investigator
Facility:
Name:
Azienda USL Toscana Centro - SOC Medicina Nucleare - Nuovo Ospedale "Santo Stefano"
Address:
City:
Prato
Zip:
59100
Country:
Italy
Status:
Active, not recruiting
Start date:
August 21, 2023
Completion date:
September 2025
Lead sponsor:
Agency:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Agency class:
Other
Source:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06136065
