Breast CancerNCT02883387
CT-Angiography Prior to DIEP Flap Breast Reconstruction
A study testing Preoperative CT angiography and No Preoperative Imaging in people with Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (DIEP). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Preoperative CT angiography and No Preoperative Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 1 Mar 2020
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planning breast reconstruction with DIEP flap
- Age 18 to 75 years
Who cannot join
- Mild to moderate loss of kidney function (Estimated Glomerular Filtration Rate (eGFR) < 60)
- Decisionally challenged
- Pregnant
- Hepatic failure
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: CT-Angiography Prior to DIEP Flap Breast Reconstruction a Randomized Controlled Trial
This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (DIEP).
- Conditions
- Breast Cancer
- Being tested
- Preoperative CT angiography, No Preoperative Imaging
- Keywords
- DIEP flap, Deep inferior epigastric artery perforator flap
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative CT angiographyOther
Patients will receive a CT scan to map the blood vessels to be used during surgery for breast reconstruction
No Preoperative ImagingOther
No imaging will be done to map blood vessels prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Preoperative CT Angiography | Experimental | Patients will receive preoperative CT angiography to map the blood vessels potentially used for reconstruction Receives: Other: Preoperative CT angiography |
| No Imaging Preoperatively | Active comparator | No preoperative vessel mapping will be done Receives: Other: No Preoperative Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Operative Time
Time required to perform breast reconstruction with DIEP flap
Measured: Time of incision to incision closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
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 University of Colorado, DenverThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David W Mathes, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883387
- Sponsor's protocol ID
- 15-2448
- Status last verified
- Feb 2022
- First submitted
- 25 Aug 2016
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-Angiography Prior to DIEP Flap Breast Reconstruction a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02883387
- Acronym / sponsor ID
- 15-2448
- Conditions
- Breast Cancer
- Keywords
- DIEP flap, Deep inferior epigastric artery perforator flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 30 Aug 2016 (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.
This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (DIEP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative CT Angiography | Experimental | Other: Preoperative CT angiographyPatients will receive preoperative CT angiography to map the blood vessels potentially used for reconstruction |
| No Imaging Preoperatively | Active comparator | Other: No Preoperative ImagingNo preoperative vessel mapping will be done |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Planning breast reconstruction with DIEP flap
- Age 18 to 75 years
Key exclusion criteria (4 listed)
- Mild to moderate loss of kidney function (Estimated Glomerular Filtration Rate (eGFR) < 60)
- Decisionally challenged
- Pregnant
- Hepatic failure
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 |
|---|---|---|
| Preoperative CT angiographyPatients will receive a CT scan to map the blood vessels to be used during surgery for breast reconstruction | Other | Preoperative CT Angiography |
| No Preoperative ImagingNo imaging will be done to map blood vessels prior to surgery | Other | No Imaging Preoperatively |
Primary outcome
Total Operative Time
Time frame: Time of incision to incision closure
Time required to perform breast reconstruction with DIEP flap
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Individual participant dataSharing planned: No
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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.
David W Mathes, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative CT angiography and No Preoperative Imaging in people with Breast Cancer, run by University of Colorado, Denver at 1 site in United States.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 24 Feb 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Operative Time (time frame: Time of incision to incision closure). 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 Feb 2022.