Breast CancerNCT04533373
Sensory Restoration After DIEP Flap Neurotization
A study testing DIEP Flap Neurotization in people with Breast Cancer and Breast Reconstruction, run by Johns Hopkins University at 1 site in United States.
Trial summary
Common goals of breast reconstruction include obtaining satisfactory breast symmetry, softness, and appropriate size and shape. Advances in surgical techniques have prompted a new goal: achieving breast sensation after reconstructive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Reconstruction, Sensory Restoration
- What is being tested?
- DIEP Flap Neurotization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 11 Sep 2024
- 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
- All patients presenting to Johns Hopkins who have had or will have mastectomy (therapeutic or prophylactic) and are planning to undergo unilateral mastectomy followed by breast reconstruction with autologous deep inferior epigastric perforator flap (DIEP) will be included.
- These patients will then be randomized in either of two treatment modalities:
- Treatment Modality 1: Breast reconstruction with DIEP flap and neurotization.
- Treatment Modality 2: Breast reconstruction with DIEP flap but without neurotization.
- 18 years of age and older
- The patient is aware of the nature of her malignancy if a malignancy has been diagnosed; understands the study purpose, requirements, and risks; and is able and willing to sign an informed consent.
Who cannot join
- Autologous reconstruction where the flap is buried.
- Exclusion criteria will encompass any patient with: diabetic neuropathy, thyroid disorders, collagen vascular disease, alcoholism, pernicious anemia, or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications.
- Pregnant or lactating women will be excluded from this study.
- Women with recurrent breast cancer will be excluded.
- Women with previous reconstructive procedures or who have previously undergone lumpectomy with radiation will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of DIEP Flap Neurotization on Sensory Restoration After Breast Reconstruction
Common goals of breast reconstruction include obtaining satisfactory breast symmetry, softness, and appropriate size and shape. Advances in surgical techniques have prompted a new goal: achieving breast sensation after reconstructive surgery. This desire has led the surgical community to investigate operative techniques for achieving this goal. However, few studies have examined the effectiveness of breast sensory restoration.
Sensory nerves are nerves responsible for sensation from skin. When a sensory nerve is cut, sensation is lost to the area supplied by the nerve. In the case of Breast reconstruction this involves the nerves supplying the skin overlying breast(s). 'Neurotization' refers to regeneration of the nerve after it has been cut. This means that the cut nerve is being repaired in order to restore its function. In Neurotization this repair is carried out using a new "source". In this case, the investigators want to restore function of the nerves that supply the skin overlying the breast(s).
Read more
The investigators will be performing breast reconstruction using tissue from the patient's abdomen and transferring it to the chest wall to repair the mastectomy defect. Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue (i.e the new "source") that is being transferred and attaching it to a nerve in the chest wall.
The Avance® Nerve graft is a nerve graft material that has been produced by Axogen, Inc. The graft is made by processing donated human nerves. This graft is used during neurotization to bridge the gap and join the nerve from the abdominal tissue to the nerve in the chest wall. The use of the graft helps the body to attach these 2 nerves and improves nerve repair.
When neurotization is done without the nerve graft there is a possibility that the surgeon may require extra nerve material to join the 2 nerves. Traditionally, in this case the surgeon would have to obtain a separate donor nerve from another part of the patient's body. This technique carries the risk of complications to part of the body that the separate donor nerve was obtained from - loss of sensation, infection or neuroma formation (an abnormal growth of nerve tissue that can cause pain, burning or tingling sensation, numbness). The Avance nerve graft avoids the need for the additional donor nerve and the possible complications associated with it.
The Avance® Nerve Graft is currently being used in some women during breast reconstruction surgery, however the effectiveness of this procedure in improving the restoration of sensation has not been proven.
Women undergoing reconstruction of one breast and at the same time using the women's own tissue as part of standard clinical care, may join.
- Conditions
- Breast Cancer, Breast Reconstruction, Sensory Restoration
- Being tested
- DIEP Flap Neurotization
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIEP Flap NeurotizationProcedure or surgery
We will be performing breast reconstruction using tissue from the patient's abdomen and transferring it to the chest wall to repair the mastectomy defect. Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue (i.e the new "source") that is being transferred and attaching it to a nerve in the chest wall.
| Study group | Role | What they receive |
|---|---|---|
| Neurotized Patients | Experimental | Neurotization will be performed at the time of reconstruction. Receives: Procedure: DIEP Flap Neurotization |
| Non-Neurotized Patients | No intervention | No Neurotization will be performed at the time of reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month Breast sensation as assessed by the AcroValTM device
Breast sensation, measured in cutaneous thresholds using the AcroValTM device.
Measured: 12-months after DIEP Flap neurotization
Secondary outcomes (14)
Breast sensation at 6 months as assessed by the AcroValTM device
Breast sensation, measured in cutaneous thresholds using the AcroValTM device.
Measured: 6 months after DIEP flap breast reconstruction
Breast sensation at 18 months as assessed by the AcroValTM device
Breast sensation, measured in cutaneous thresholds using the AcroValTM device.
Measured: 18 months after DIEP flap breast reconstruction
Breast sensation at 24 months as assessed by the AcroValTM device
Breast sensation, measured in cutaneous thresholds using the AcroValTM device.
Measured: 24 months after DIEP flap breast reconstruction
Breast-specific health-related quality of life using the Breast-Q®
The Breast-Q® is a validated patient reported outcomes questionnaire used to assess Breast specific patient satisfaction and Health-related quality of life. The Breast-Q is comprised of 2 domains - i) Satisfaction domains and ii) Well-being domains, which are further divided into sub-domains. We will be using 3 satisfaction sub-domains:
- Satisfaction with breasts ii) Satisfaction with Nipple iii) Satisfaction with outcome and 3 well-being sub-domains:
- Psychosocial well-being ii) Sexual well-being and iii) Physical well-being
Each sub-domain will be scored on a scale of 0-100, where higher scores will indicate higher satisfaction.
Measured: 6 months after DIEP flap breast reconstruction
Breast-specific health-related quality of life using the Breast-Q®
The Breast-Q® is a validated patient reported outcomes questionnaire used to assess Breast specific patient satisfaction and Health-related quality of life. The Breast-Q is comprised of 2 domains - i) Satisfaction domains and ii) Well-being domains, which are further divided into sub-domains. We will be using 3 satisfaction sub-domains:
- Satisfaction with breasts ii) Satisfaction with Nipple iii) Satisfaction with outcome and 3 well-being sub-domains:
- Psychosocial well-being ii) Sexual well-being and iii) Physical well-being
Each sub-domain will be scored on a scale of 0-100, where higher scores will indicate higher satisfaction.
Measured: 12 months after DIEP flap breast reconstruction
Breast-specific health-related quality of life using the Breast-Q®
The Breast-Q® is a validated patient reported outcomes questionnaire used to assess Breast specific patient satisfaction and Health-related quality of life. The Breast-Q is comprised of 2 domains - i) Satisfaction domains and ii) Well-being domains, which are further divided into sub-domains. We will be using 3 satisfaction sub-domains:
- Satisfaction with breasts ii) Satisfaction with Nipple iii) Satisfaction with outcome and 3 well-being sub-domains:
- Psychosocial well-being ii) Sexual well-being and iii) Physical well-being
Each sub-domain will be scored on a scale of 0-100, where higher scores will indicate higher satisfaction.
Measured: 18 months after DIEP flap breast reconstruction
Breast-specific health-related quality of life using the Breast-Q®
The Breast-Q® is a validated patient reported outcomes questionnaire used to assess Breast specific patient satisfaction and Health-related quality of life. The Breast-Q is comprised of 2 domains - i) Satisfaction domains and ii) Well-being domains, which are further divided into sub-domains. We will be using 3 satisfaction sub-domains:
- Satisfaction with breasts ii) Satisfaction with Nipple iii) Satisfaction with outcome and 3 well-being sub-domains:
- Psychosocial well-being ii) Sexual well-being and iii) Physical well-being
Each sub-domain will be scored on a scale of 0-100, where higher scores will indicate higher satisfaction.
Measured: 24 months after DIEP flap breast reconstruction
General health-related quality of life using the SF-12
The SF-12 is a multipurpose short form (SF) survey with 12 questions, all selected from the SF-36 Health Survey. It has 2 components - i) Physical Health Composite score and ii) Mental Health Composite score. Each composite score is marked on a scale of 0-100, where a higher score indicates higher quality of life.
Measured: 6 months after DIEP flap breast reconstruction
General health-related quality of life using the SF-12
The SF-12 is a multipurpose short form (SF) survey with 12 questions, all selected from the SF-36 Health Survey. It has 2 components - i) Physical Health Composite score and ii) Mental Health Composite score. Each composite score is marked on a scale of 0-100, where a higher score indicates higher quality of life.
Measured: 12 months after DIEP flap breast reconstruction
General health-related quality of life using the SF-12
The SF-12 is a multipurpose short form (SF) survey with 12 questions, all selected from the SF-36 Health Survey. It has 2 components - i) Physical Health Composite score and ii) Mental Health Composite score. Each composite score is marked on a scale of 0-100, where a higher score indicates higher quality of life.
Measured: 18 months after DIEP flap breast reconstruction
General health-related quality of life using the SF-12
The SF-12 is a multipurpose short form (SF) survey with 12 questions, all selected from the SF-36 Health Survey. It has 2 components - i) Physical Health Composite score and ii) Mental Health Composite score. Each composite score is marked on a scale of 0-100, where a higher score indicates higher quality of life.
Measured: 24 months after DIEP flap breast reconstruction
Change in breast sensation as assessed by the AcroValTM device
Change in breast sensation from baseline, measured in cutaneous thresholds using the AcroValTM device.
Measured: Baseline, 6, 12, 18 and 24 months after DIEP flap breast reconstruction
Change in breast-specific health-related quality of life using the Breast-Q®
The Breast-Q® is a validated patient reported outcomes questionnaire used to assess Breast specific patient satisfaction and Health-related quality of life. The Breast-Q is comprised of 2 domains - i) Satisfaction domains and ii) Well-being domains, which are further divided into sub-domains. We will be using 3 satisfaction sub-domains:
- Satisfaction with breasts ii) Satisfaction with Nipple iii) Satisfaction with outcome and 3 well-being sub-domains:
- Psychosocial well-being ii) Sexual well-being and iii) Physical well-being
Each sub-domain will be scored on a scale of 0-100, where higher scores will indicate higher satisfaction.
Measured: Baseline, 6, 12, 18, and 24 months after DIEP flap breast reconstruction
Change in general health-related quality of life using the SF-12
The SF-12 is a multipurpose short form (SF) survey with 12 questions, all selected from the SF-36 Health Survey. It has 2 components - i) Physical Health Composite score and ii) Mental Health Composite score. Each composite score is marked on a scale of 0-100, where a higher score indicates higher quality of life.
Measured: Baseline, 6, 12, 18, and 24 months after DIEP flap breast reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start1 Dec 2020
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Why it stopped: IRB expired
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 Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Axogen Corporation
- Responsible party
- Sponsor
- Investigators
- Gedge D Rosson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04533373
- Sponsor's protocol ID
- IRB00167074
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2020
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of DIEP Flap Neurotization on Sensory Restoration After Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04533373
- Acronym / sponsor ID
- IRB00167074
- Conditions
- Breast Cancer, Breast Reconstruction, Sensory Restoration
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB expired
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Axogen Corporation
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 31 Aug 2020 (actual)
- 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.
Common goals of breast reconstruction include obtaining satisfactory breast symmetry, softness, and appropriate size and shape. Advances in surgical techniques have prompted a new goal: achieving breast sensation after reconstructive surgery. This desire has led the surgical community to investigate operative techniques for achieving this goal. However, few studies have examined the effectiveness of breast sensory restoration.
Sensory nerves are nerves responsible for sensation from skin. When a sensory nerve is cut, sensation is lost to the area supplied by the nerve. In the case of Breast reconstruction this involves the nerves supplying the skin overlying breast(s). 'Neurotization' refers to regeneration of the nerve after it has been cut. This means that the cut nerve is being repaired in order to restore its function. In Neurotization this repair is carried out using a new "source". In this case, the investigators want to restore function of the nerves that supply the skin overlying the breast(s).
The investigators will be performing breast reconstruction using tissue from the patient's abdomen and transferring it to the chest wall to repair the mastectomy defect. Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue (i.e the new "source") that is being transferred and attaching it to a nerve in the chest wall.
The Avance® Nerve graft is a nerve graft material that has been produced by Axogen, Inc. The graft is made by processing donated human nerves. This graft is used during neurotization to bridge the gap and join the nerve from the abdominal tissue to the nerve in the chest wall. The use of the graft helps the body to attach these 2 nerves and improves nerve repair.
When neurotization is done without the nerve graft there is a possibility that the surgeon may require extra nerve material to join the 2 nerves. Traditionally, in this case the surgeon would have to obtain a separate donor nerve from another part of the patient's body. This technique carries the risk of complications to part of the body that the separate donor nerve was obtained from - loss of sensation, infection or neuroma formation (an abnormal growth of nerve tissue that can cause pain, burning or tingling sensation, numbness). The Avance nerve graft avoids the need for the additional donor nerve and the possible complications associated with it.
The Avance® Nerve Graft is currently being used in some women during breast reconstruction surgery, however the effectiveness of this procedure in improving the restoration of sensation has not been proven.
Women undergoing reconstruction of one breast and at the same time using the women's own tissue as part of standard clinical care, may join.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurotized Patients | Experimental | Procedure: DIEP Flap NeurotizationNeurotization will be performed at the time of reconstruction. |
| Non-Neurotized Patients | No intervention | –No Neurotization will be performed at the time of reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients presenting to Johns Hopkins who have had or will have mastectomy (therapeutic or prophylactic) and are planning to undergo unilateral mastectomy followed by breast reconstruction with autologous deep inferior epigastric perforator flap (DIEP) will be included.
- 18 years of age and older
- The patient is aware of the nature of her malignancy if a malignancy has been diagnosed; understands the study purpose, requirements, and risks; and is able and willing to sign an informed consent.
Key exclusion criteria (5 listed)
- Autologous reconstruction where the flap is buried.
- Exclusion criteria will encompass any patient with: diabetic neuropathy, thyroid disorders, collagen vascular disease, alcoholism, pernicious anemia, or any other severe underlying peripheral neuropathy including chemotherapy-induced neuropathy or neuropathy induced by other medications.
- Pregnant or lactating women will be excluded from this study.
- Women with recurrent breast cancer will be excluded.
- Women with previous reconstructive procedures or who have previously undergone lumpectomy with radiation 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 |
|---|---|---|
| DIEP Flap NeurotizationWe will be performing breast reconstruction using tissue from the patient's abdomen and transferring it to the chest wall to repair the mastectomy defect. Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue (i.e the new "source") that is being transferred and attaching it to a nerve in the chest wall. | Procedure or surgery | Neurotized Patients |
Primary outcome
12-month Breast sensation as assessed by the AcroValTM device
Time frame: 12-months after DIEP Flap neurotization
Breast sensation, measured in cutaneous thresholds using the AcroValTM device.
14 secondary outcomes
Breast sensation at 6 months as assessed by the AcroValTM device
Time frame: 6 months after DIEP flap breast reconstruction
Breast sensation at 18 months as assessed by the AcroValTM device
Time frame: 18 months after DIEP flap breast reconstruction
Breast sensation at 24 months as assessed by the AcroValTM device
Time frame: 24 months after DIEP flap breast reconstruction
Breast-specific health-related quality of life using the Breast-Q®
Time frame: 6 months after DIEP flap breast reconstruction
Breast-specific health-related quality of life using the Breast-Q®
Time frame: 12 months after DIEP flap breast reconstruction
Breast-specific health-related quality of life using the Breast-Q®
Time frame: 18 months after DIEP flap breast reconstruction
Breast-specific health-related quality of life using the Breast-Q®
Time frame: 24 months after DIEP flap breast reconstruction
General health-related quality of life using the SF-12
Time frame: 6 months after DIEP flap breast reconstruction
General health-related quality of life using the SF-12
Time frame: 12 months after DIEP flap breast reconstruction
General health-related quality of life using the SF-12
Time frame: 18 months after DIEP flap breast reconstruction
General health-related quality of life using the SF-12
Time frame: 24 months after DIEP flap breast reconstruction
Change in breast sensation as assessed by the AcroValTM device
Time frame: Baseline, 6, 12, 18 and 24 months after DIEP flap breast reconstruction
Change in breast-specific health-related quality of life using the Breast-Q®
Time frame: Baseline, 6, 12, 18, and 24 months after DIEP flap breast reconstruction
Change in general health-related quality of life using the SF-12
Time frame: Baseline, 6, 12, 18, and 24 months after DIEP flap breast reconstruction
Results and safety
The study was stopped early (reason given: IRB expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Gedge D Rosson, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DIEP Flap Neurotization in people with Breast Cancer and Breast Reconstruction, run by Johns Hopkins University 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Apr 2025. 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 was stopped early (reason given: IRB expired). 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?
12-month Breast sensation as assessed by the AcroValTM device (time frame: 12-months after DIEP Flap neurotization). 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 11 Apr 2025.