Breast CancerNCT01292772
The Effects of Radiation in Reconstructed Breasts
An observational study of Breast Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- contract-enhanced MRI and Unilateral Adjuvant Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 5 May 2019
- 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 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The target population will consist of patients with a diagnosis of unilateral breast cancer who elect to undero bilateral mastectomy with immediate free flap reconstruction. Patients will be treated by members of the Division of Plastic and Reconstructive Surgery and will receive postoperative radiation therapy to the affected breast.
Who may be able to join
- Female patients between 18 and 90 years of age.
- Patients with a diagnosis of unilateral breast cancer who elect to undergo bilateral mastectomy with immediate free flap reconstruction.
- Patients must also have a locally advanced tumor that requires adjuvant radiation therapy following reconstruction.
Who cannot join
- Women who do not undergo immediate, bilateral breast reconstruction using a free flap.
- Women who do not require unilateral, adjuvant radiation therapy
- Women who are pregnant
- Women who have altered renal function, defined as a personal history of diabetic, hypertensive or autoimmune nephropathy and/or on routine preoperative testing are found to have a serum creatinine greater than or equal to 1.3
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
Read the detailed description
Immediate breast reconstruction following mastectomy has become an increasingly popular and accepted treatment option among breast cancer patients. This change in practice has resulted in a significant number of patients who undergo radiation therapy after breast reconstruction. Following irradiation, the reconstructed breast often experiences fibrotic contracture, volume loss, altered pigmentation, or some combination thereof, producing an asymmetric and aesthetically compromised result. The effects of radiation on reconstructed breasts as well as the implications that such changes have for timing of reconstructive surgery, post-operative management and surveillance imaging are topics of growing importance in plastic surgery, radiology and surgical oncology.
- Conditions
- Breast Cancer
- Being tested
- contract-enhanced MRI, Unilateral Adjuvant Radiation Therapy
- Keywords
- breast cancer, bilateral mastectomy, immediate breast reconstruction, locally advanced unilateral breast cancer, bilateral mastectomy for prophylaxis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contract-enhanced MRIProcedure or surgery
Patients will have contrast-enhanced MRI of the breasts.
Unilateral Adjuvant Radiation TherapyRadiation
The study group will consist breasts receiving post-operative radiation, and the control group will consist of the patient's breasts on the non-radiated side. In this way, patients will act as their own control.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reconstructed Breast Volume
This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Measured: up to 1 year after radiation
Vascular Fibrosis
This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Measured: up to 1 year after radiation
Dermal Thickness
This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts
Measured: up to 1 year after radiation
Secondary outcomes (6)
Presence of Fat Necrosis in the Breast
This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Measured: up to 1 year after radiation
Evidence of Cancer Recurrence
This will assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Measured: up to 1 year after radiation
Symmetry
This will be assessed at 2 points; before radiation and 1 year after radiation is completed between the 2 breasts.
Measured: up to 1 year after radiation
Hyperpigmentation
This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Measured: up to 1 year after radiation
Contracture
This will be assessed at 2 points:before radiation and 1 year after radiation is completed between the 2 breasts.
Measured: up to 1 year after radiation
Aesthetic Result
This will be assessed at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Measured: up to 1 year after radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2016
- Study completion5 May 2019
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 Abramson Cancer Center at Penn MedicineThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292772
- Sponsor's protocol ID
- UPCC 12110
- Status last verified
- Apr 2020
- First submitted
- 1 Feb 2011
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Radiation Therapy on the Reconstructed Breast: An Evaluation Using MR Imaging
- ClinicalTrials.gov ID
- NCT01292772
- Acronym / sponsor ID
- UPCC 12110
- Conditions
- Breast Cancer
- Keywords
- breast cancer, bilateral mastectomy, immediate breast reconstruction, locally advanced unilateral breast cancer, bilateral mastectomy for prophylaxis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Dec 2010 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 10 Feb 2011 (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 primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
Detailed description
Immediate breast reconstruction following mastectomy has become an increasingly popular and accepted treatment option among breast cancer patients. This change in practice has resulted in a significant number of patients who undergo radiation therapy after breast reconstruction. Following irradiation, the reconstructed breast often experiences fibrotic contracture, volume loss, altered pigmentation, or some combination thereof, producing an asymmetric and aesthetically compromised result. The effects of radiation on reconstructed breasts as well as the implications that such changes have for timing of reconstructive surgery, post-operative management and surveillance imaging are topics of growing importance in plastic surgery, radiology and surgical oncology.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population will consist of patients with a diagnosis of unilateral breast cancer who elect to undero bilateral mastectomy with immediate free flap reconstruction. Patients will be treated by members of the Division of Plastic and Reconstructive Surgery and will receive postoperative radiation therapy to the affected breast.
Key inclusion criteria (3 listed)
- Female patients between 18 and 90 years of age.
- Patients with a diagnosis of unilateral breast cancer who elect to undergo bilateral mastectomy with immediate free flap reconstruction.
- Patients must also have a locally advanced tumor that requires adjuvant radiation therapy following reconstruction.
Key exclusion criteria (4 listed)
- Women who do not undergo immediate, bilateral breast reconstruction using a free flap.
- Women who do not require unilateral, adjuvant radiation therapy
- Women who are pregnant
- Women who have altered renal function, defined as a personal history of diabetic, hypertensive or autoimmune nephropathy and/or on routine preoperative testing are found to have a serum creatinine greater than or equal to 1.3
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 |
|---|---|---|
| contract-enhanced MRIPatients will have contrast-enhanced MRI of the breasts. | Procedure or surgery | – |
| Unilateral Adjuvant Radiation TherapyThe study group will consist breasts receiving post-operative radiation, and the control group will consist of the patient's breasts on the non-radiated side. In this way, patients will act as their own control. | Radiation | – |
Primary outcome
Reconstructed Breast Volume
Time frame: up to 1 year after radiation
This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Vascular Fibrosis
Time frame: up to 1 year after radiation
This will be compared at 2 points: before radiation and 1 year after radiation is completed between the 2 breasts.
Dermal Thickness
Time frame: up to 1 year after radiation
This will be compared at 2 pionts: before radiation and 1 year after radiation is completed between the 2 breasts
6 secondary outcomes
Presence of Fat Necrosis in the Breast
Time frame: up to 1 year after radiation
Evidence of Cancer Recurrence
Time frame: up to 1 year after radiation
Symmetry
Time frame: up to 1 year after radiation
Hyperpigmentation
Time frame: up to 1 year after radiation
Contracture
Time frame: up to 1 year after radiation
Aesthetic Result
Time frame: up to 1 year after radiation
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 8 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cancer, run by Abramson Cancer Center at Penn Medicine 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 3 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 8 Apr 2020. 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?
Reconstructed Breast Volume (time frame: up to 1 year after radiation). The study lists 3 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 8 Apr 2020.