Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06136065
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2023-09-13
Brief 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
Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Organization:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
Study Overview
Official Title:
68Ga-FAPI-46 Positron Emission Tomography - Computerized Tomography for Molecular Assessment of Fibroblast Activation
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAPI
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-003786-38 | EUDRACT_NUMBER | None | None |
| 2024-511659-17-00 | CTIS | None | None |