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Not yet recruiting NCT07180433

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

No phase Interventional Breast Neoplasm Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FAPI PET/MR.
Who it may be relevant to
Registry conditions: Breast Neoplasm Female. Basic parameters: 18 years — 80 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Diagnostic test FAPI PET/MR
    The patients will be injected intravenously with 2 MBq/kg 18F-FAPI, 60 minutes before the PET/MRI acquisition. The PET/MRI examinations will be performed on a Siemens Biograph mMR (Siemens Healthcare, Erlangen, Germany) with software version VE11P. Static PET will be acquired simultaneously with MRI using two protocols; a one bed position protocol in prone position covering the breast and a whole body 4-5 bed position protocol in supine position covering brain to thighs. Total acquisition time o

Primary outcome measures

  • Diagnostic accuracy of 18F-FAPI-PET/MRI in detection of breast cancer lesions [Time frame: Baseline]
Secondary outcome measures (5)
  • Correlation of standardized uptake values of 18F-FAPI to histologically proven characteristics of the breast cancer lesions [Time frame: Baseline]
  • Diagnostic accuracy of 18F-FAPI PET/MR compared to MR only in prediction/evaluation of response to neoadjuvant chemotherapy [Time frame: From baseline to surgery (~3-6 months)]
  • Diagnostic accuracy of 18F-FAPI PET/MR compared to standard CT/bone scintigraphy in staging of breast cancer [Time frame: Baseline]
  • Diagnostic accuracy of 18F-FAPI PET/MR compared to CT/bone scintigraphy in detection of recurrence. [Time frame: Baseline]
  • Diagnostic accuracy of 18F-FAPI PET/MR compared to 18F-FDG PET/CT. [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Inclusion criteria are accepting to undergo 18F-FAPI PET/MRI examinations and
  • diagnosed with local invasive breast cancer,
  • scheduled for neoadjuvant therapy as primary treatment,
  • has recurrent or new breast cancer, or
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07180433 · 639856/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗