NCT02111239

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2013

Completed
8 months until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 24, 2016

Status Verified

October 1, 2016

Enrollment Period

6.4 years

First QC Date

August 1, 2013

Last Update Submit

October 21, 2016

Conditions

Breast Cancer

Keywords

DIEPDIEP flapBreast reconstructionBreast CancerCTAMRA

Outcome Measures

Primary Outcomes (2)

  • Time for flap dissection

    Time to reach exposure of perforators combined with time for flap elevation will be recorded during the surgical procedure.

    1 day - during surgery

  • Change in BREAST-Q Scores

    Self-administered quality of life and outcomes questionnaire for women that undergo breast reconstruction.

    Preoperatively, Postoperatively at 3 weeks, 3 months, 12 months

Secondary Outcomes (4)

  • Whether change in operative procedure occurred during surgery

    1 day

  • Change in Memorial Pain Assessment Card (MPAC) Scores

    Baseline, postoperatively on the first 4 days, and at 3 weeks, 3 months and 12 months

  • NASA-Task Load Index (TLX)

    once - immediately postoperatively

  • Economic Outcome

    1 year

Study Arms (3)

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.

Device: CTA

MRA

EXPERIMENTAL

Patients randomized to this group will undergo a preoperative MRA scan.

Device: MRA

Interventions

CTADEVICE

pelvic/abdominal CTA scan

Also known as: preoperative CTA, computed tomography angiography
CTA
MRADEVICE

pelvic/abdominal MRA scan

Also known as: preoperative MRA, magnetic resonance angiogram
MRA

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • candidate for DIEP flap breast reconstruction
  • speak/read/write English
  • have undergone or will undergo unilateral or bilateral mastectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Computed Tomography AngiographyMagnetic Resonance Angiography

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomographyMagnetic Resonance ImagingAngiographyDiagnostic Techniques, Cardiovascular

Study Officials

  • Joan Lipa, MD, MSc

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2013

First Posted

April 11, 2014

Study Start

June 1, 2011

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

October 24, 2016

Record last verified: 2016-10

Locations

CA(1)