Trial Outcomes & Findings for MRI in Evaluating Early Response to Chemotherapy in Women With Infiltrating Breast Cancer (NCT NCT00462696)
NCT ID: NCT00462696
Last Updated: 2025-10-06
Results Overview
MRI vascular permeability is measured using Kep index (Rate constant between extracellular extravascular space (EES) and plasma). Kep index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.
COMPLETED
NA
16 participants
two months after start of neoadjuvant chemotherapy
2025-10-06
Participant Flow
Participant milestones
| Measure |
Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer
The patient will be recruited during a multidisciplinary team meeting (MDT). The histological diagnosis of invasive breast cancer will be confirmed based on the results of the micro-biopsy, which will be performed during the MDT meeting, after the initial MRI scan. The patient will submit her signed informed consent form. The MRI will be performed before the micro-biopsy so as not to distort the measurement of the tumor volume by a possible post-collection hematoma.
Neoadjuvant chemotherapy: as per standard practice
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer
n=16 Participants
The patient will be recruited during a multidisciplinary team meeting (MDT). The histological diagnosis of invasive breast cancer will be confirmed based on the results of the micro-biopsy, which will be performed during the MDT meeting, after the initial MRI scan. The patient will submit her signed informed consent form. The MRI will be performed before the micro-biopsy so as not to distort the measurement of the tumor volume by a possible post-collection hematoma.
Neoadjuvant chemotherapy: as per standard practice
|
|---|---|
|
Age, Continuous
|
47 years
n=16 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=16 Participants
|
|
Region of Enrollment
France
|
16 participants
n=16 Participants
|
PRIMARY outcome
Timeframe: two months after start of neoadjuvant chemotherapyPopulation: Outcome could not be assessed. outcome was based on the assessment of MRI index by two radiologists. Only one radiologist assessed the index.
MRI vascular permeability is measured using Kep index (Rate constant between extracellular extravascular space (EES) and plasma). Kep index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: two months after start of neoadjuvant chemotherapyPopulation: Outcome could not be assessed. outcome was based on the assessment of MRI index by two radiologists. Only one radiologist assessed the index.
MRI vascular permeability is measured using HA index (Hepatic Artery index or Hepatic Arterial perfusion). HA index will be measured at the second cycle of neoadjuvant chemotherapy. MRI will be read independently by two radiologists experienced in breast imaging and breast MRI, blind to the results found by the other, in order to assess the reproducibility of the measurement.
Outcome measures
Outcome data not reported
Adverse Events
Woment Treated With Neoadjuvant Chemotherapy for Breast Cancer
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Simone Mathoulin-Pélissier, Director of Clinical Trials Unit
Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place