Assess the Variation of Apparent Diffusion CoefficientADCNCT01956513
Contribution of MRI in the Evaluation of Apparent Diffusion Coefficient and Prediction of Response to Neoadjuvant Chemotherapy in Breast Cancer
A study testing MRI (Magnetic resonance imaging) in people with Assess the Variation of Apparent Diffusion Coefficient, run by Centre Jean Perrin.
Trial summary
The main objective of the study is to assess the sensitivity and the specificity of the variation of apparent diffusion coefficient for prediction, after a course of neoadjuvant chemotherapy or after modification of the treatment sequence, the pathological response at the end of chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Assess the Variation of Apparent Diffusion Coefficient
- What is being tested?
- MRI (Magnetic resonance imaging)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years.
- Patient suffering from a breast tumor, regardless of the stage and size
- Patient requiring neoadjuvant chemotherapy
- Patient has the ability to undergo 18F-FDG-PET at baseline, at end of cycle 1 and at the end of neoadjuvant treatment before surgery
- Compulsory affiliation to a social security system.
- Obtaining informed consent in writing, signed and dated.
Who cannot join
- Patient with cognitive or psychiatric disorders.
- Patient deprived of liberty by a court or administrative.
- Patient with signs against the achievement of MRI, mammography and ultrasound
- Patient metastatic
- Patient with prior chemotherapy, radiotherapy and hormone therapy for her breast cancer
- Pregnant women, current lactation
- Patient suffering from uncontrolled diabetes (> 11 mmol / L)
About this study
Official title: Etude ADC Apport de l'IRM Dans l'évaluation du Coefficient de Diffusion Apparent et prédiction de la réponse à la chimiothérapie néoadjuvante Dans le Cancer du Sein
The main objective of the study is to assess the sensitivity and the specificity of the variation of apparent diffusion coefficient for prediction, after a course of neoadjuvant chemotherapy or after modification of the treatment sequence, the pathological response at the end of chemotherapy
- Being tested
- MRI (Magnetic resonance imaging)
- Keywords
- ADC, breast cancer, complete pathological response
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI (Magnetic resonance imaging)Other
MRI will be realised at the beginning of the study, after a cycle of chemotherapy or at changement of sequence and at the end of chemotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of apparent diffusion coefficient before / after a cycle of neoadjuvant chemotherapy or before / after modification of the treatment sequence and correlated with histologic response
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMar 2012
- Primary completionOct 2013 (estimated)
- Study completionOct 2013 (estimated)
Why it stopped: We have finally no financial support and any patients have been included.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess the Variation of Apparent Diffusion CoefficientStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne BAILLY, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956513
- Sponsor's protocol ID
- Etude ADC
- Acronym
- ADC
- Status last verified
- Oct 2013
- First submitted
- 16 Mar 2012
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude ADC Apport de l'IRM Dans l'évaluation du Coefficient de Diffusion Apparent et prédiction de la réponse à la chimiothérapie néoadjuvante Dans le Cancer du Sein
- ClinicalTrials.gov ID
- NCT01956513
- Acronym / sponsor ID
- ADC / Etude ADC
- Keywords
- ADC, breast cancer, complete pathological response
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We have finally no financial support and any patients have been included.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to assess the sensitivity and the specificity of the variation of apparent diffusion coefficient for prediction, after a course of neoadjuvant chemotherapy or after modification of the treatment sequence, the pathological response at the end of chemotherapy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age> 18 years.
- Patient suffering from a breast tumor, regardless of the stage and size
- Patient requiring neoadjuvant chemotherapy
- Patient has the ability to undergo 18F-FDG-PET at baseline, at end of cycle 1 and at the end of neoadjuvant treatment before surgery
- Compulsory affiliation to a social security system.
Key exclusion criteria (7 listed)
- Patient with cognitive or psychiatric disorders.
- Patient deprived of liberty by a court or administrative.
- Patient with signs against the achievement of MRI, mammography and ultrasound
- Patient metastatic
- Patient with prior chemotherapy, radiotherapy and hormone therapy for her breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI (Magnetic resonance imaging)MRI will be realised at the beginning of the study, after a cycle of chemotherapy or at changement of sequence and at the end of chemotherapy. | Other | – |
Primary outcome
Variation of apparent diffusion coefficient before / after a cycle of neoadjuvant chemotherapy or before / after modification of the treatment sequence and correlated with histologic response
Time frame: One year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne BAILLY, MD principal investigator
Centre Jean Perrin
Questions about this trial
What is this clinical trial studying?
A study testing MRI (Magnetic resonance imaging) in people with Assess the Variation of Apparent Diffusion Coefficient, run by Centre Jean Perrin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of apparent diffusion coefficient before / after a cycle of neoadjuvant chemotherapy or before / after modification of the treatment sequence and correlated with histologic response (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2013.