Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06540872
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-11
Brief Title:
Multimodal Imaging With FAPI-PETMRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multimodal Imaging With FAPI-PETMRI in Breast Carcinoma-In-Situ for Detection of Occult Invasive Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MI-CISDIR
Brief Summary:
DCIS ductal carcinoma in situ is a common pre-stage for breast cancer The goal of this clinical trial is to learn if FAPI-PETMRI an imaging technique with a weakly radioactive drug helps to diagnose hidden invasive breast cancer in participants with DCIS The main question it aims to answer is
How good can FAPI-PETMRI diagnose hidden invasive breast cancer in DCIS
Researchers will compare FAPI-PETMRI results to tissue samples obtained from surgery treatment to see if the FAPI-PETMRI images show invasive breast cancer certainly
Participants will
receive the radioactive drug and lie in an imaging device for 45 minutes including a break
visit the clinic once again for a checkup and test
How good can FAPI-PETMRI diagnose hidden invasive breast cancer in DCIS
Researchers will compare FAPI-PETMRI results to tissue samples obtained from surgery treatment to see if the FAPI-PETMRI images show invasive breast cancer certainly
Participants will
receive the radioactive drug and lie in an imaging device for 45 minutes including a break
visit the clinic once again for a checkup and test
Detailed Description:
Ductal carcinoma in situ DCIS is a common precursor to breast cancer where abnormal cells are present within the milk ducts without breaking through their walls in situ If these cancerous cells have already breached the boundaries of the milk ducts it is referred to as invasive carcinoma About half of these precancerous conditions develop further into invasive carcinomas over time However since doctors cannot precisely predict this at an individual level treating DCIS often involves removing the affected tissue to prevent progression towards invasive cancer Typically diagnosis relies on performing a biopsy during which cells from the altered tissue are extracted and examined under a microscope Unfortunately determining whether or not an invasive carcinoma has developed is not always possible with certainty with this method indeed about one quarter of cases involving existing invasive carcinomas might remain undetected by conventional biopsy procedures
Consequently being able to ascertain before surgery if an invasive carcinoma exists or not would be highly beneficial This study examines a novel method that could potentially enhance the discovery of hidden also called occult invasive carcinomas Specifically it employs positron emission tomography PET utilizing a radiopharmaceutical agent known as 68GaGa-FAPI-46 This compound selectively targets and binds to fibroblast activation protein FAP abundant on surfaces of tumor-associated fibroblasts By tagging this structure with a radiotracer researchers aim to achieve precise visualization and assessment of tumor extent For the PET examination a minimal dose of the radiopharmaceutical is administered intravenously while sensitive cameras capture images of particular body sections externally PET Additionally magnetic resonance imaging MRI of the breast is conducted concurrently to ensure anatomical orientation image enhancement attenuation correction and additional information acquisition
The trial visits will be scheduled during the regular treatment process These will not extend the participants overall treatment duration significantly as all measures within the scope of the study typically occur within 30 days but no more than 51 days During this period effective contraception is necessary
Researchers will then compare the imaging results to the pathology ground truth to evaluate the feasibility of the method
Consequently being able to ascertain before surgery if an invasive carcinoma exists or not would be highly beneficial This study examines a novel method that could potentially enhance the discovery of hidden also called occult invasive carcinomas Specifically it employs positron emission tomography PET utilizing a radiopharmaceutical agent known as 68GaGa-FAPI-46 This compound selectively targets and binds to fibroblast activation protein FAP abundant on surfaces of tumor-associated fibroblasts By tagging this structure with a radiotracer researchers aim to achieve precise visualization and assessment of tumor extent For the PET examination a minimal dose of the radiopharmaceutical is administered intravenously while sensitive cameras capture images of particular body sections externally PET Additionally magnetic resonance imaging MRI of the breast is conducted concurrently to ensure anatomical orientation image enhancement attenuation correction and additional information acquisition
The trial visits will be scheduled during the regular treatment process These will not extend the participants overall treatment duration significantly as all measures within the scope of the study typically occur within 30 days but no more than 51 days During this period effective contraception is necessary
Researchers will then compare the imaging results to the pathology ground truth to evaluate the feasibility of the method
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None