Breast CancerNCT02111239
Preoperative Imaging in DIEP Flap Breast Reconstruction
A study testing CTA and MRA in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether preoperative abdominal imaging using either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and patient outcomes in DIEP flap breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CTA and MRA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2011to Nov 2017
- 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
- candidate for DIEP flap breast reconstruction
- speak/read/write English
- have undergone or will undergo unilateral or bilateral mastectomy
Who cannot join
- previous abdominal surgery that may preclude a DIEP flap reconstruction
- active smoker
- BMI over 35
- severe claustrophobia
- sensitivity to intravenous CT contrast medium (Visipaque 320) or MR contrast medium (Gadovist 1.0)
- urgency of surgery that precludes study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes
The purpose of this study is to determine whether preoperative abdominal imaging using either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and patient outcomes in DIEP flap breast reconstruction.
Read the detailed description
This study will prospectively compare the clinical, economic and patient outcomes of preoperative imaging using either CTA or MRA with those of no preoperative imaging in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Subjects will randomly undergo either a CTA scan or an MRA scan, or no scan (control) preoperatively. An operative plan based on perforator size and course will be devised by an interventional radiologist and a plastic surgeon. The DIEP flap procedure will be planned for controls.
Subjects will not be told if the operative plan is changed intraoperatively. Flap dissection time and changes in operative plan will be recorded intraoperatively and surgeon stress will be evaluated following surgery. Pain and narcotic use will be evaluated preoperatively and on days 1-4 postoperatively. The Breast-Q will be completed preoperatively and at 3 weeks, 3 months and 12 months postoperatively. Groups will be compared in terms of all variables measured.
- Conditions
- Breast Cancer
- Being tested
- CTA, MRA
- Keywords
- DIEP, DIEP flap, Breast reconstruction, Breast Cancer, CTA, MRA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTADevice
Also called preoperative CTA, computed tomography angiography
pelvic/abdominal CTA scan
MRADevice
Also called preoperative MRA, magnetic resonance angiogram
pelvic/abdominal MRA scan
| Study group | Role | What they receive |
|---|---|---|
| No imaging | No intervention | No preoperative imaging is performed for this group |
| CTA | Experimental | Patients randomized to this group will undergo a preoperative CTA scan. Receives: Device: CTA |
| MRA | Experimental | Patients randomized to this group will undergo a preoperative MRA scan. Receives: Device: MRA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for flap dissection
Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure.
Measured: 1 day - during surgery
Change in BREAST-Q Scores
Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction.
Measured: Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months
Secondary outcomes (4)
Whether change in operative procedure occurred during surgery
Change of operative plan either prior to surgery as a result of preoperative imaging, or intra-operatively, will be recorded
Measured: 1 day
Change in Memorial Pain Assessment Card (MPAC) Scores
Self-administered questionnaire consisting of 4 questions related to pain, pain relief, and mood.
Measured: Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months
NASA-Task Load Index (TLX)
Completed by the operating surgeon to evaluate workload based on 6 scales: mental demand, physical demand, temporal demand, performance, effort and frustration.
Measured: once - immediately postoperatively
Economic Outcome
The costs of medical imaging and operating expenses will be calculated and compared between study groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startJun 2011
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Joan Lipa, MD, MSc, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111239
- Sponsor's protocol ID
- Sunnybrook106-2011
- Status last verified
- Oct 2016
- First submitted
- 1 Aug 2013
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Imagining in DIEP Flap Breast Reconstruction: A Randomized Controlled Trial Evaluating Cost and Patient-Reported Outcomes
- ClinicalTrials.gov ID
- NCT02111239
- Acronym / sponsor ID
- Sunnybrook106-2011
- Conditions
- Breast Cancer
- Keywords
- DIEP, DIEP flap, Breast reconstruction, Breast Cancer, CTA, MRA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- Jun 2011
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 11 Apr 2014 (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 purpose of this study is to determine whether preoperative abdominal imaging using either CT angiogram (CTA), or MR angiogram (MRA) will impact perforator dissection time, cost, and patient outcomes in DIEP flap breast reconstruction.
Detailed description
This study will prospectively compare the clinical, economic and patient outcomes of preoperative imaging using either CTA or MRA with those of no preoperative imaging in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Subjects will randomly undergo either a CTA scan or an MRA scan, or no scan (control) preoperatively. An operative plan based on perforator size and course will be devised by an interventional radiologist and a plastic surgeon. The DIEP flap procedure will be planned for controls.
Subjects will not be told if the operative plan is changed intraoperatively. Flap dissection time and changes in operative plan will be recorded intraoperatively and surgeon stress will be evaluated following surgery. Pain and narcotic use will be evaluated preoperatively and on days 1-4 postoperatively. The Breast-Q will be completed preoperatively and at 3 weeks, 3 months and 12 months postoperatively. Groups will be compared in terms of all variables measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No imaging | No intervention | –No preoperative imaging is performed for this group |
| CTA | Experimental | Device: CTAPatients randomized to this group will undergo a preoperative CTA scan. |
| MRA | Experimental | Device: MRAPatients randomized to this group will undergo a preoperative MRA scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- candidate for DIEP flap breast reconstruction
- speak/read/write English
- have undergone or will undergo unilateral or bilateral mastectomy
Key exclusion criteria (6 listed)
- previous abdominal surgery that may preclude a DIEP flap reconstruction
- active smoker
- BMI over 35
- severe claustrophobia
- sensitivity to intravenous CT contrast medium (Visipaque 320) or MR contrast medium (Gadovist 1.0)
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 |
|---|---|---|
| CTAAlso: preoperative CTA, computed tomography angiographypelvic/abdominal CTA scan | Device | CTA |
| MRAAlso: preoperative MRA, magnetic resonance angiogrampelvic/abdominal MRA scan | Device | MRA |
Primary outcome
Time for flap dissection
Time frame: 1 day - during surgery
Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure.
Change in BREAST-Q Scores
Time frame: Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months
Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction.
4 secondary outcomes
Whether change in operative procedure occurred during surgery
Time frame: 1 day
Change in Memorial Pain Assessment Card (MPAC) Scores
Time frame: Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months
NASA-Task Load Index (TLX)
Time frame: once - immediately postoperatively
Economic Outcome
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2016.
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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.
Joan Lipa, MD, MSc principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CTA and MRA in people with Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Time for flap dissection (time frame: 1 day - during surgery). The study lists 2 primary outcomes in all. 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 24 Oct 2016.