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Piloting 18F-FAPI PET/MRI for Applications in Breast Cancer

S

St. Olavs Hospital

Status

Not yet enrolling

Conditions

Breast Neoplasm Female

Treatments

Diagnostic Test: FAPI PET/MR

Study type

Interventional

Funder types

Other

Identifiers

NCT07180433
639856/23

Details and patient eligibility

About

Breast cancer is the most common type of cancer in Norwegian women, with 4,224 new cases in 2022. More precise diagnosis are expected to result in more accurate assessment of treatment effect, and to contribute to both providing better treatment and reducing overtreatment. Fibroblast activating protein (FAP) is expressed in the tumor stroma of 90% of all epithelial-based tumors, including breast tumors. Inhibitors for this protein (FAPI) has been developed for use as radioactive tracers. Breast tumors of various histopathological types, and local metastatic lymph nodes, have shown high uptake for such tracers. The main aim of this project is to establish 18F-FAPI PET/MRI for use in breast cancer in a wide range of disease stages. We will evaluate how FAPI PET/MRI correlates with histopathological assessment, the method's ability to grade tumors - including assessment of treatment - compared to CT, scintigraphy and FDG PET/CT, and ability to detect local recurrence.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Inclusion criteria are accepting to undergo 18F-FAPI PET/MRI examinations and

    1. diagnosed with local invasive breast cancer,
    2. scheduled for neoadjuvant therapy as primary treatment,
    3. has recurrent or new breast cancer, or
    4. scheduled for neoadjuvant therapy as primary treatment with FDG-PET/CT applied for staging.

Exclusion criteria

  • other primary malignancies than breast cancer, renal insufficiency or know allergy towards contrast agents, and MR incompatible implants.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

FAPI-PET/MRI
Experimental group
Description:
The patients will be injected 2 MBq/kg 18F-FAPI, prior to PET/MRI acquisition
Treatment:
Diagnostic Test: FAPI PET/MR

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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