Diagnostic PET/CT (Positron Emission Tomography/Computed Tomography) examination with the radiotracer 68Ga-FAPI-46 to assess fibroblast activation and risk in solid tumors

68Ga-FAPI-46 PET-CT for molecular assessment of fibroblast activation and risk assessment in solid tumors - FAPI Basket

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003786-38-IT

Enrollment

Registered

2022-11-29

Start date

2023-03-17

Completion date

Unknown

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumors MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: 68Ga-FAPI-46_IRSTIRCCS Product Code: [68Ga-FAPI-46_IRSTIRCCS] Pharmaceutical Form: Solution for injection Current Sponsor code: 68Ga-FAPI-46_IRSTIRCCS Concentration unit: MBq megabecquer

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients must have histologically or cytologically solid tumors at any stage 2. 18F-FDG PET/CT scan dubious or inconclusive 3. Male or Female, aged>18 years 4. ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: 1. Participation in another clinical trial with any investigational agents within 30 days prior to study entry. 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 FAPI or other agents used in the study. 4. Inability to remain still for the entire duration of the exam 5. Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the sensitivity of 68Ga-FAPI-46 PET/CT defined as the ratio between the number of 68Ga-FAPI-46 PET/CT positive patients and the number of patients with solid tumors presenting with FDG PET/CT scan dubious or inconclusive.;Secondary Objective: 68Ga-FAPI-46 PET/CT sensitivity by tumor histotype 68Ga-FAPI-46 PET/CT sensitivity by lesion site Safety Description of 68Ga-FAPI-46 uptake Exploratory Objective: Description of 68Ga-FAPI-46 uptake after immunotherapy or other therapy;Primary end point(s): The primary endpoint is the evaluation of the detection rate of 68Ga-FAPI-46 PET/CT, defined as the proportion of FAPI- positive patients and the total number of recruited patients. A positive patient is defined as a patient with at least one FAPI-positive lesion.;Timepoint(s) of evaluation of this end point: 30 months	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the sensitivity of 68Ga-FAPI-46 PET/CT defined as the ratio between the number of 68Ga-FAPI-46 PET/CT positive patients and the number of patients with solid tumors presenting with FDG PET/CT scan dubious or inconclusive.;Secondary Objective: 68Ga-FAPI-46 PET/CT sensitivity by tumor histotype 68Ga-FAPI-46 PET/CT sensitivity by lesion site Safety Description of 68Ga-FAPI-46 uptake Exploratory Objective: Description of 68Ga-FAPI-46 uptake after immunotherapy or other therapy;Primary end point(s): The primary endpoint is the evaluation of the detection rate of 68Ga-FAPI-46 PET/CT, defined as the proportion of FAPI- positive patients and the total number of recruited patients. A positive patient is defined as a patient with at least one FAPI-positive lesion.;Timepoint(s) of evaluation of this end point: 30 months

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Secondary

Measure	Time frame
Secondary end point(s): Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each tumor histology. The results of visually interpreted PET/CT images will be compared with histopathological findings (from biopsy or surgery, whenever possible) or follow-up clinical data as the standard; Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each lesion site and proportion of 68Ga-FAPI-46 PET/CT-positive lesions over the total number of lesions for each lesion site; 68Ga-FAPI-46 uptake in terms of SUV; Safety defined as the number and percentage of patients undergoing grade 1 to 4 adverse events according to CTCAE version 5.0 until 30 days post 68Ga-FAPI-46 PET/CT.; 68Ga-FAPI-46 uptake after immunotherapy or other therapies in terms of SUV;Timepoint(s) of evaluation of this end point: 30 months; 30 months; 30 months; 30 months; 30 months	—

Measure

Time frame

Secondary end point(s): Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each tumor histology. The results of visually interpreted PET/CT images will be compared with histopathological findings (from biopsy or surgery, whenever possible) or follow-up clinical data as the standard; Proportion of 68Ga-FAPI-46 PET/CT-positive patients over the total number of patients undergoing 68Ga-FAPI-46 PET/CT for each lesion site and proportion of 68Ga-FAPI-46 PET/CT-positive lesions over the total number of lesions for each lesion site; 68Ga-FAPI-46 uptake in terms of SUV; Safety defined as the number and percentage of patients undergoing grade 1 to 4 adverse events according to CTCAE version 5.0 until 30 days post 68Ga-FAPI-46 PET/CT.; 68Ga-FAPI-46 uptake after immunotherapy or other therapies in terms of SUV;Timepoint(s) of evaluation of this end point: 30 months; 30 months; 30 months; 30 months; 30 months

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Countries

Italy

Contacts

Public ContactCentro di Coordinamento studi IRST

IRCCS IRST

cc.ubsc@irst.emr.it0544287167

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026