Breast CancerNCT01666899
Effect of Radiation on Tissue for Delayed Breast Reconstruction
A study testing Skin and blood vessel procedures in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of radiation therapy following mastectomy on skin and blood vessels and to use information gathered to determine an ideal time for breast reconstruction after radiation. 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?
- Skin and blood vessel procedures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to 15 Jun 2015
- 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
- Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy.
- Patients who meet criteria 1, who plan on postmastectomy breast reconstruction
Who cannot join
- Male patients
- Patients under the age of 18
- Patients of advanced age (greater than 75)
- Patients with comorbidities that affect wound healing.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the effects of radiation therapy following mastectomy on skin and blood vessels and to use information gathered to determine an ideal time for breast reconstruction after radiation.
Read the detailed description
In the setting of post-mastectomy radiation therapy delayed autologous reconstruction, favored by many attempts to avoid complications encountered with radiating the immediately reconstructed breast. The timing of delayed reconstruction is however not known. The goal of this proposal is to study the gross, structural and vascular changes in radiated mastectomy skin in addition to possible structural and flow changes of the underlying internal mammary vessels over time. We plan to use these objective findings as a basis for determining an ideal time frame for delayed autologous breast reconstruction.
Sequential mastectomy skin specimens will be obtained from 20 patients undergoing post-mastectomy radiation therapy over a 24 month period and these specimens will be evaluated histologically. These same patients will also undergo serial examinations and photographic documentation of gross skin changes. Skin perfusion will be assessed by laser Doppler imaging and internal mammary vessel structure, and flow characteristics will be assessed by color Doppler sonography.
Based on these studies, we will elucidate short and long term changes in radiated breast skin, showing inflammatory, structural and perfusion patterns that can be correlated with optimal conditions for reconstruction. This has the potential to dramatically change practice patterns of delayed reconstruction for many reconstructive surgeons and more importantly restore what patients loose with mastectomy in a consistent, timely fashion. There is also potential for improved outcomes of delayed breast reconstruction by decreasing the number of reconstructions performed too soon after completion of radiation.
- Conditions
- Breast Cancer
- Being tested
- Skin and blood vessel procedures
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin and blood vessel proceduresProcedure or surgery
Biopsies, skin blood flow studies and ultrasound studies will be performed as described.
| Study group | Role | What they receive |
|---|---|---|
| Skin and blood vessel procedures | Experimental | All patients will be placed into Arm 1. They will undergo punch biopsies of the breast skin at the time of mastectomy and at 2, 4, 6, 8 and 12 months after completion of radiation therapy. Three more biopsies will be taken at 3, 6, and 12 months after completion of reconstruction. Patients will also undergo skin blood flow studies with a laser imaging device prior to each biopsy procedure. Ultrasound studies of the chest vessels will be performed 4 times over the course of the study- once prior to radiation and at 2, 6 and 12 months after radiation. Receives: Procedure: Skin and blood vessel procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
Measured: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
Secondary outcomes (1)
To evaluate the vascular density of the skin and perfusion changes following radiation therapy.
Measured: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startOct 2012
- Primary completion15 Jun 2015
- Study completion15 Jun 2015
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 Michigan Rogel 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeyiza Momoh, MD, Principal investigator, Univeristy of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666899
- Sponsor's protocol ID
- 2012.032
- Other IDs
- HUM00059038
- Status last verified
- May 2017
- First submitted
- 14 Aug 2012
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radiation on Tissue for Delayed Breast Reconstruction
- ClinicalTrials.gov ID
- NCT01666899
- Acronym / sponsor ID
- 2012.032
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- 15 Jun 2015 (actual)
- Study completion
- 15 Jun 2015 (actual)
- First posted
- 16 Aug 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.
The purpose of this study is to investigate the effects of radiation therapy following mastectomy on skin and blood vessels and to use information gathered to determine an ideal time for breast reconstruction after radiation.
Detailed description
In the setting of post-mastectomy radiation therapy delayed autologous reconstruction, favored by many attempts to avoid complications encountered with radiating the immediately reconstructed breast. The timing of delayed reconstruction is however not known. The goal of this proposal is to study the gross, structural and vascular changes in radiated mastectomy skin in addition to possible structural and flow changes of the underlying internal mammary vessels over time. We plan to use these objective findings as a basis for determining an ideal time frame for delayed autologous breast reconstruction.
Sequential mastectomy skin specimens will be obtained from 20 patients undergoing post-mastectomy radiation therapy over a 24 month period and these specimens will be evaluated histologically. These same patients will also undergo serial examinations and photographic documentation of gross skin changes. Skin perfusion will be assessed by laser Doppler imaging and internal mammary vessel structure, and flow characteristics will be assessed by color Doppler sonography.
Based on these studies, we will elucidate short and long term changes in radiated breast skin, showing inflammatory, structural and perfusion patterns that can be correlated with optimal conditions for reconstruction. This has the potential to dramatically change practice patterns of delayed reconstruction for many reconstructive surgeons and more importantly restore what patients loose with mastectomy in a consistent, timely fashion. There is also potential for improved outcomes of delayed breast reconstruction by decreasing the number of reconstructions performed too soon after completion of radiation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin and blood vessel procedures | Experimental | Procedure: Skin and blood vessel proceduresAll patients will be placed into Arm 1. They will undergo punch biopsies of the breast skin at the time of mastectomy and at 2, 4, 6, 8 and 12 months after completion of radiation therapy. Three more biopsies will be taken at 3, 6, and 12 months after completion of reconstruction. Patients will also undergo skin blood flow studies with a laser imaging device prior to each biopsy procedure. Ultrasound studies of the chest vessels will be performed 4 times over the course of the study- once prior to radiation and at 2, 6 and 12 months after radiation. |
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)
- Patients with invasive breast cancer who will require mastectomy and postmastectomy radiation therapy.
- Patients who meet criteria 1, who plan on postmastectomy breast reconstruction
Key exclusion criteria (4 listed)
- Male patients
- Patients under the age of 18
- Patients of advanced age (greater than 75)
- Patients with comorbidities that affect wound healing.
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 |
|---|---|---|
| Skin and blood vessel proceduresBiopsies, skin blood flow studies and ultrasound studies will be performed as described. | Procedure or surgery | Skin and blood vessel procedures |
Primary outcome
To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy.
Time frame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
1 secondary outcome
To evaluate the vascular density of the skin and perfusion changes following radiation therapy.
Time frame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction
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 30 May 2017.
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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.
Adeyiza Momoh, MD principal investigator
Univeristy of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin and blood vessel procedures in people with Breast Cancer, run by University of Michigan Rogel Cancer Center 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 30 May 2017. 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?
To evaluate cellular and histologic changes in mastectomy skin over time following completion of radiation therapy. (time frame: 2, 4, 6, 8, 12 months post radiation therapy; 3, 6, 12 months post reconstruction). 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 30 May 2017.