Ductal Breast Carcinoma in SituNCT01729832
Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer
A study testing breast reconstruction and intraoperative imaging in people with Ductal Breast Carcinoma in Situ and Lobular Breast Carcinoma in Situ, run by Ohio State University Comprehensive Cancer Center.
Trial summary
Many hospitals, including the Ohio State University Medical Center, will take pictures of the blood vessels in a patient's abdomen before they decide to perform a breast reconstruction using the patient's own tissue. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Recurrent Breast Cancer
- What is being tested?
- breast reconstruction and intraoperative imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2011to Jul 2012
- 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
- Patients with histologically confirmed breast carcinoma or breast carcinoma in situ desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap breast reconstruction
- Patients must be candidates for elective surgery, without clinically significant cardiac or pulmonary disease (New York Heart Association [NYHA] class III/IV), without infection requiring antibiotics, and without serious illness requiring the use of steroids
- Patients must have normal kidney function and no allergy to intravenous (IV) dye
Who cannot join
- Patients with previous abdominal donor site flaps will be excluded along with patients with previous extensive surgery to the anterior abdomen
- Patients with a weight of over 300 pounds or a body size not supported by the CT scanner will be excluded
- Patients who are expected to undergo postoperative radiation therapy will be excluded
About this study
Official title: Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.
Many hospitals, including the Ohio State University Medical Center, will take pictures of the blood vessels in a patient's abdomen before they decide to perform a breast reconstruction using the patient's own tissue. These pictures are called computed tomography (CT) angiograms and are like a map of each patient's anatomy. However, no study has been reported that determined how accurate these pictures are at showing the surgeon where all of the blood vessels were located. This study will try to determine if these pictures are missing any blood vessels that are found during surgery and if the pictures show the correct location of the vessels
Read the detailed description
PRIMARY OBJECTIVES:
- To analyze the accuracy of preoperative CT angiography in determining the location of perforator vessels. Through the use of an intraoperative navigation system, we will objectively locate perforators during surgery and compare the results to the preoperative imaging assessment of the flap's vascular anatomy.
II. To determine whether the preoperative CT angiogram allows the microsurgeon to correctly identify the perforators that are ultimately used as the pedicle for the flap.
OUTLINE:
Patients undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction using the StealthStation navigation system.
After completion of study treatment, patients are followed up at 1-2 weeks and 1 month, then every 3 months for 2 years.
- Conditions
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Being tested
- breast reconstruction, intraoperative imaging
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breast reconstructionProcedure or surgery
Also called Mammaplasty
Undergo DIEP flap breast reconstruction using the StealthStation navigation system
intraoperative imagingProcedure or surgery
Undergo DIEP flap breast reconstruction using the StealthStation navigation system
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (image-guided breast reconstruction) | Experimental | Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system. Receives: Procedure: breast reconstruction; Procedure: intraoperative imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
Measured: Up to 2 years
Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer
Measured: Up to 2 years
Secondary outcomes (1)
Position of the vessels on the imaging correlate to actual location on the abdominal wall for those perforator vessels that are identified both on preoperative review of the images and located during flap dissection
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study start10 Jan 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Breast Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ergun Kocak, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729832
- Sponsor's protocol ID
- OSU-10106
- Other IDs
- NCI-2012-00693
- Status last verified
- Apr 2017
- First submitted
- 14 Nov 2012
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.
- ClinicalTrials.gov ID
- NCT01729832
- Acronym / sponsor ID
- OSU-10106
- Conditions
- Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 10 Jan 2011 (actual)
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 20 Nov 2012 (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.
Many hospitals, including the Ohio State University Medical Center, will take pictures of the blood vessels in a patient's abdomen before they decide to perform a breast reconstruction using the patient's own tissue. These pictures are called computed tomography (CT) angiograms and are like a map of each patient's anatomy. However, no study has been reported that determined how accurate these pictures are at showing the surgeon where all of the blood vessels were located. This study will try to determine if these pictures are missing any blood vessels that are found during surgery and if the pictures show the correct location of the vessels
Detailed description
PRIMARY OBJECTIVES:
- To analyze the accuracy of preoperative CT angiography in determining the location of perforator vessels. Through the use of an intraoperative navigation system, we will objectively locate perforators during surgery and compare the results to the preoperative imaging assessment of the flap's vascular anatomy.
II. To determine whether the preoperative CT angiogram allows the microsurgeon to correctly identify the perforators that are ultimately used as the pedicle for the flap.
OUTLINE:
Patients undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction using the StealthStation navigation system.
After completion of study treatment, patients are followed up at 1-2 weeks and 1 month, then every 3 months for 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (image-guided breast reconstruction) | Experimental | Procedure: breast reconstruction, Procedure: intraoperative imagingPatients undergo DIEP flap breast reconstruction using the StealthStation navigation system. |
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)
- Patients with histologically confirmed breast carcinoma or breast carcinoma in situ desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap breast reconstruction
- Patients must be candidates for elective surgery, without clinically significant cardiac or pulmonary disease (New York Heart Association [NYHA] class III/IV), without infection requiring antibiotics, and without serious illness requiring the use of steroids
- Patients must have normal kidney function and no allergy to intravenous (IV) dye
Key exclusion criteria (3 listed)
- Patients with previous abdominal donor site flaps will be excluded along with patients with previous extensive surgery to the anterior abdomen
- Patients with a weight of over 300 pounds or a body size not supported by the CT scanner will be excluded
- Patients who are expected to undergo postoperative radiation therapy will be excluded
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 |
|---|---|---|
| breast reconstructionAlso: MammaplastyUndergo DIEP flap breast reconstruction using the StealthStation navigation system | Procedure or surgery | Supportive care (image-guided breast reconstruction) |
| intraoperative imagingUndergo DIEP flap breast reconstruction using the StealthStation navigation system | Procedure or surgery | Supportive care (image-guided breast reconstruction) |
Primary outcome
The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
Time frame: Up to 2 years
Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer
Time frame: Up to 2 years
1 secondary outcome
Position of the vessels on the imaging correlate to actual location on the abdominal wall for those perforator vessels that are identified both on preoperative review of the images and located during flap dissection
Time frame: Up to 2 years
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 13 Apr 2017.
- JameslineLink provided by the sponsor.
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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.
Ergun Kocak, MD principal investigator
Ohio State University
Questions about this trial
What is this clinical trial studying?
A study testing breast reconstruction and intraoperative imaging in people with Ductal Breast Carcinoma in Situ and Lobular Breast Carcinoma in Situ, run by Ohio State University Comprehensive Cancer Center.
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: withdrawn, as of the sponsor's last update on 13 Apr 2017. 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?
The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images (time frame: Up to 2 years). 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 13 Apr 2017.