Breast ReconstructionDIEPNCT00748722
Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography
An observational study of Breast Reconstruction, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM) and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Reconstruction
- What is being tested?
- CT Angiography
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2008to Aug 2009
- Phase
- Observational
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients, age 18-60 years eligible for lower abdominal breast reconstruction
Who may be able to join
- Female, age 18-60 years
- Appropriate for lower abdominal based breast reconstruction.
- Consented the use of CT Angiography
Who cannot join
- Age under 18 years or over 60.
- Pregnant women
- Allergy to iodine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography for DIEP Breast Reconstruction
Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM) and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast reconstruction. With significant variation in the vascular anatomy of the abdominal wall, preoperative imaging is essential for preoperative planning and reducing intraoperative error.
The quest continues for optimal preoperative assessment. Computed tomographic angiography has recently been proposed as a noninvasive modality for this purpose. It provides the location of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.
In this study we will perform preoperative lower abdominal computed tomographic angiography in DIEP flap breast reconstruction patients.
Read the detailed description
Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM) and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast reconstruction. With significant variation in the vascular anatomy of the abdominal wall, preoperative imaging is essential for preoperative planning and reducing intraoperative error.
The quest continues for optimal preoperative assessment. Computed tomographic angiography has recently been proposed as a noninvasive modality for this purpose. It provides the location of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.
In this study we will perform preoperative lower abdominal computed tomographic angiography in DIEP flap breast reconstruction patients.
We plan to study 20 patients, eligible for lower abdominal-based breast reconstruction.
- Conditions
- Breast Reconstruction
- Being tested
- CT Angiography
- Keywords
- Breast reconstruction, Perforator flaps, CT Angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT AngiographyDevice
Also called Iodine
Injection of contrast material (iodine)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Female patients, age 18-60 years, suitable for breast reconstruction using the lower abdominal tissue. Receives: Device: CT Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year from starting date
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 posted9 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Yoav Barnea, MD, Study chair, Tel Aviv Medical CenterArie Blachar, MD, Principal investigator, Tel Aviv Medical CenterEyal Gur, MD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748722
- Sponsor's protocol ID
- TASMC-08-YB-0181-CTIL
- Acronym
- DIEP
- Status last verified
- Sep 2008
- First submitted
- 15 Jul 2008
- Last updated
- 9 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rozen WM, Palmer KP, Suami H, Pan WR, Ashton MW, Corlett RJ, Taylor GI. The DIEA branching pattern and its relationship to perforators: the importance of preoperative computed tomographic angiography for DIEA perforator flaps. Plast Reconstr Surg. 2008 Feb;121(2):367-373. doi: 10.1097/01.prs.0000298313.28983.f4.
PubMed 18300951
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Operative Imaging of Abdominal Wall Perforators Using CT Angiography for DIEP Breast Reconstruction
- ClinicalTrials.gov ID
- NCT00748722
- Acronym / sponsor ID
- DIEP / TASMC-08-YB-0181-CTIL
- Conditions
- Breast Reconstruction
- Keywords
- Breast reconstruction, Perforator flaps, CT Angiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- First posted
- 9 Sep 2008 (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.
Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM) and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast reconstruction. With significant variation in the vascular anatomy of the abdominal wall, preoperative imaging is essential for preoperative planning and reducing intraoperative error.
The quest continues for optimal preoperative assessment. Computed tomographic angiography has recently been proposed as a noninvasive modality for this purpose. It provides the location of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.
In this study we will perform preoperative lower abdominal computed tomographic angiography in DIEP flap breast reconstruction patients.
Detailed description
Abdominal donor-site flaps, including the transverse rectus abdominis musculocutaneous (TRAM) and deep inferior epigastric artery perforator flaps(DIEP), are standard in autologous breast reconstruction. With significant variation in the vascular anatomy of the abdominal wall, preoperative imaging is essential for preoperative planning and reducing intraoperative error.
The quest continues for optimal preoperative assessment. Computed tomographic angiography has recently been proposed as a noninvasive modality for this purpose. It provides the location of the perforator vessels, diameter and anatomic course in regards to the rectus muscle.
In this study we will perform preoperative lower abdominal computed tomographic angiography in DIEP flap breast reconstruction patients.
We plan to study 20 patients, eligible for lower abdominal-based breast reconstruction.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: CT AngiographyFemale patients, age 18-60 years, suitable for breast reconstruction using the lower abdominal tissue. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients, age 18-60 years eligible for lower abdominal breast reconstruction
Key inclusion criteria (3 listed)
- Female, age 18-60 years
- Appropriate for lower abdominal based breast reconstruction.
- Consented the use of CT Angiography
Key exclusion criteria (3 listed)
- Age under 18 years or over 60.
- Pregnant women
- Allergy to iodine
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 |
|---|---|---|
| CT AngiographyAlso: IodineInjection of contrast material (iodine) | Device | 1 |
Primary outcome
1 year from starting date
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 9 Sep 2008.
- Results publication: PubMed 18300951Rozen WM, Palmer KP, Suami H, Pan WR, Ashton MW, Corlett RJ, Taylor GI. The DIEA branching pattern and its relationship to perforators: the importance of preoperative computed tomographic angiography for DIEA perforator flaps. Plast Reconstr Surg. 2008 Feb;121(2):367-373. doi: 10.1097/01.prs.0000298313.28983.f4.
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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.
Yoav Barnea, MD study chair
Tel Aviv Medical Center
Arie Blachar, MD principal investigator
Tel Aviv Medical Center
Eyal Gur, MD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 3 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 9 Sep 2008. 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 Israel. 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?
1 year from starting date (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00748722, which also lists 1 linked publication.
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 9 Sep 2008.