Angiomammography and Neoadjuvant Chemotherapy
Primary Purpose
Breast Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Angiomammography
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Female aged 18 and over
- Histologically proven breast cancer by large gauge needle
- No evidence of distant metastasis
- Neoadjuvant chemotherapy with or without concomitant targeted therapy
- Breast tumor initially measurable by clinical examination
Exclusion Criteria:
- Refusal to perform the biopsy or surgery
- Pregnant or possibly pregnant woman
Usual contraindication to contrast product
- Significant kidney failure
- Allergy to contrast medium
- frank hyperthyroidism
- Usual contraindications to MRI
Sites / Locations
- St-Sacrement HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Neoadjuvant chemotherapy
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with a pCR accoreding to angiomammography, based on a 50% reduction in lesion size at angiomammography
Prediction of pCR using angiomammography after cycle 2 of neoadjuvant chemotherapy, based on a 50% reduction in lesion size at angiomammography
Secondary Outcome Measures
Full Information
NCT ID
NCT05402930
First Posted
May 20, 2022
Last Updated
August 29, 2023
Sponsor
CHU de Quebec-Universite Laval
1. Study Identification
Unique Protocol Identification Number
NCT05402930
Brief Title
Angiomammography and Neoadjuvant Chemotherapy
Official Title
Usefulness of Angiomammography for Predicting the Response to Neoadjuvant Chemotherapy in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Quebec-Universite Laval
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The best prognostic factor following neoadjuvant chemotherapy is the pathological complete response (pCR). pCR is defined as the absence of invading cells in the breast and lymph nodes following neoadjuvant chemotherapy treatment. Since patients with pCR have a better prognosis than those without pCR, some studies have evaluated different methods to predict pCR early in treatment. Thus, patients who do not respond optimally to treatment could be identified early and changed treatment in order to maximize the chances of pCR and avoid the morbidity of poorly effective treatments. To do this, several modalities have been proposed, including MRI, mammography, ultrasound, positron emission tomography, elastography, and serial biopsies, but these techniques have shown predictive and sometimes expensive. Nevertheless, assessment of tumor response after cycle 2 has been suggested to be appropriate for the prediction of pCR.
The main objective of this study is to compare the performance of two diagnostic modalities, namely CESM and MRI, in the evaluation of the response of a malignant breast tumor to neoadjuvant chemotherapy and the prediction of pCR. The radiological response will also be compared to the clinical response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neoadjuvant chemotherapy
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Angiomammography
Intervention Description
Patients will receive their care in a standard manner. Breast MRI is one modality used by physicians to monitor response to neoadjuvant chemotherapy and will therefore be used as standard. A CESM exam will be added at the same time as the MRI.
Patients will have a physical exam, breast MRI and CESM before the start of chemotherapy (less than 2 weeks). These examinations will be repeated after cycle 2 (±1 week) and at the end of chemotherapy. After each cycle of chemotherapy, the tumor will be measured in two axes by the attending physician.
Histological examination of the surgical specimen will be used to determine the pCR. Responses observed on MRI and CESM will be compared to pCR.
Primary Outcome Measure Information:
Title
Number of patients with a pCR accoreding to angiomammography, based on a 50% reduction in lesion size at angiomammography
Description
Prediction of pCR using angiomammography after cycle 2 of neoadjuvant chemotherapy, based on a 50% reduction in lesion size at angiomammography
Time Frame
Cycle 2 (each cycle being 21 days), i.e., after the chemotherapy on day 1 of cycle 2 and before cycle 3.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female aged 18 and over
Histologically proven breast cancer by large gauge needle
No evidence of distant metastasis
Neoadjuvant chemotherapy with or without concomitant targeted therapy
Breast tumor initially measurable by clinical examination
Exclusion Criteria:
Refusal to perform the biopsy or surgery
Pregnant or possibly pregnant woman
Usual contraindication to contrast product
Significant kidney failure
Allergy to contrast medium
frank hyperthyroidism
Usual contraindications to MRI
Facility Information:
Facility Name
St-Sacrement Hospital
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S4L8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Charles Hogue
Phone
4185254444
Ext
82424
Email
jean-charles.hogue@crchudequebec.ulaval.ca
12. IPD Sharing Statement
Learn more about this trial
Angiomammography and Neoadjuvant Chemotherapy
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