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LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04606030
Recruitment Status : Recruiting
First Posted : October 28, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
University of Chicago
Stanford University
Information provided by (Responsible Party):
Fibralign Corporation

Brief Summary:
To investigate whether the addition of Fibralign's BioBridge® Collagen Matrix (BioBridge) devices to the standard surgery for vascularized lymph node transfer will improve the outcome of surgical treatment in lymphedema of the upper arm.

Condition or disease Intervention/treatment Phase
Lymphedema Edema Device: BioBridge® Collagen Matrix Procedure: Vascularized Lymph Node Transfer (VLNT) Not Applicable

Detailed Description:

The proposed study utilizes Fibralign's BioBridge® Collagen Matrix (BioBridge), a sterile implantable biocompatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen. The Class II device was cleared by CDRH Division of Surgical Devices on 8 January 2016 under 510(k) K151083. The device will be used for soft tissue surgical support at the time of vascularized lymph node transplant surgery (VLNT); the device will be used, specifically, for surgical support of the lymphatic component of the soft tissue.

Primary endpoint is the post surgical % change in excess limb volume, measured at 12 months following the surgical procedure.

Secondary endpoints are change in quality of life scores measured by LLIS and change in lymphatic function as measured by indocyanine green (ICG) fluorescence imaging.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, control arm
Masking: Single (Outcomes Assessor)
Masking Description: Partially Blinded: Patients will be informed which group they are randomized into and given the option to opt out of the study. Investigators (other than surgeons conducting surgery) and study personnel involved in patient measurements will be unaware of the patient treatment option.
Primary Purpose: Treatment
Official Title: LymphBridge: Prospective Evaluation of the BioBridge Scaffold as an Adjunct to Lymph Node Transplant for Upper Extremity Lymphedema
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema
Drug Information available for: Collagen

Arm Intervention/treatment
Experimental: BioBridge treatment group
Vascularized Lymph Node Transplant surgery (VLNT) supplemented by BioBridge Collagen Matrix implantation
Device: BioBridge® Collagen Matrix
BioBridge Collagen Matrix (BioBridge) is a sterile implantable bio-compatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen. The Class II device was cleared by CDRH Division of Surgical Devices on 8 January 2016 under 510(k) K151083. The device will be used for soft tissue surgical support at the time of vascularized lymph node transplant surgery (VLNT); the device will be used, specifically, for surgical support of the lymphatic component of the soft tissue.

Procedure: Vascularized Lymph Node Transfer (VLNT)
Micro-surgical procedure for vascularized lymph node transfer (VLNT)

Active Comparator: Control group
Vascularized Lymph Node Transplant surgery (VLNT) only
Procedure: Vascularized Lymph Node Transfer (VLNT)
Micro-surgical procedure for vascularized lymph node transfer (VLNT)




Primary Outcome Measures :
  1. Excess limb volume change [ Time Frame: Baseline and 12 months after treatment ]
    Change in % of (excess) limb volume in the intervention group relative to control group


Secondary Outcome Measures :
  1. LLIS survey [ Time Frame: Baseline and 12 months after treatment ]
    Lymphedema-specific instrument to measure impairments, activity limitations, and participation restrictions in those living with any extremity lymphedema

  2. L-Dex bioimpedance spectroscopy. [ Time Frame: Baseline and 12 months after treatment ]
    Change in the Lymphedema Index (L-Dex) in the intervention group relative to control group. The L-Dex score has the requisite sensitivity and specificity to detect the differences in retained interstitial fluid that might discriminate the therapeutic responses of the treated patients. It has been established that the normal range of the L-Dex score is in the interval from -10 to +10 units; the higher score the more difference is in the retained interstitial fluid between the affected and unaffected limbs.

  3. Histology [ Time Frame: Baseline and 12 months after treatment ]
    Change in cutaneous histological architecture. The impact of treatment on the cutaneous histopathology will be evaluated through the use of an empirically derived scoring system and will be performed by a dermatopathologist.

  4. ICG fluorescence imaging [ Time Frame: Baseline and 12 months after treatment ]
    Change in lymphatic function assessed by ICG fluorescence imaging



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The subject must be a breast cancer survivor, at least 3 years beyond completion of cancer therapy, free of clinical disease, and eligible for surgical intervention. Participants who are not able to safely undergo general anesthesia and/or perioperative care for VLNT are excluded.

  • Ages 18 to 75 years (inclusive)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2
  • Life expectancy > 2 years
  • Acquired (secondary) upper limb lymphedema secondary to breast cancer treatment
  • The participant must be eligible for surgical intervention
  • Swelling of 1 limb that is not completely reversed by elevation or compression
  • Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system
  • Participants must have no evidence of disease (NED), have completed breast cancer therapy 3 years prior to enrollment; use of endocrine therapy is allowed.
  • Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen
  • Willingness to comply with recommended regimen of self care, with consistent use of compression garments from screening through the entire study duration (through the safety follow up visit), excluding the first 3 weeks postoperatively where patients are required to not wear compression. Self bandaging, use of nighttime compression garments, and intermittent pneumatic compression devices are allowed, but the procedures and regimens are expected to remain consistent from screening though the entire study duration.
  • Consistent use of an appropriately sized compression garment for daytime use.
  • Limb volume (LV) in the affected limb and unaffected limb must be at least 10% of each other.
  • Evidence of abnormal bioimpedance ratio, if feasible, based upon unilateral disease: L Dex > 10 units.
  • Willingness and ability to comply with all study procedures, including measurement of skin biopsy, and preoperative and postoperative imaging studies.
  • Willingness and ability to understand, and to sign a written informed consent form document

Exclusion Criteria:

  • Edema arising from increased capillary filtration will be excluded (venous incompetence).
  • Inability to safely undergo general anesthesia and/or perioperative care related to vascularized lymph node transfer
  • Concurrent participation in a clinical trial of any other investigational drug or therapy, regardless of indication, within 1 month before screening or 5 times the drug's half life, whichever is longer
  • Recent initiation (≤ 12 weeks) of CDPT for lymphedema
  • Other medical condition that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure
  • Other medical condition that could result in symptoms overlapping those of lymphedema in the affected limb (eg, pain, swelling, decreased range of motion)
  • History of clotting disorder (hypercoagulable state)
  • Chronic (persistent) infection in the affected limb
  • Infection of the lymphedema limb within 1 month prior to screening
  • Currently receiving chemotherapy or radiation therapy
  • Current evidence, or a history of malignancy within the past 3 years (except for non melanoma skin cancer or cervical cancer in situ treated with curative intent). If the participant has undergone cancer treatment, this must have been completed > 3 years prior to enrollment.
  • Significant or chronic renal insufficiency (defined as serum creatinine > 2.5 mg/dL or an estimated glomerular filtration rate [eGFR] < 30 mL/min at screening) or requires dialytic support
  • Hepatic dysfunction, defined as alanine transaminase (ALT) or aspartate transaminase (AST) levels > 3 × upper limit of the normal range (ULN) and/or bilirubin level > 2 × ULN at screening
  • Absolute neutrophil count < 1500 mm3 at screening
  • Hemoglobin concentration < 9 g/dL at screening
  • Body Mass Index (BMI) >35
  • Known sensitivity to porcine products
  • Anaphylaxis to iodine
  • Pregnancy or nursing
  • Substance abuse (such as alcohol or drug abuse) within 6 months prior to screening
  • Any reason (in addition to those listed above) that, in the opinion of the investigator, precludes full participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04606030


Contacts
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Contact: Janine Grohar 773-702-0316 jgrohar@bsd.uchicago.edu

Locations
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United States, California
Stanford University Not yet recruiting
Stanford, California, United States, 94305
Contact: Dung H Nguyen, MD, PharmD         
United States, Illinois
The University of Chicago Biological Sciences Division/University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Janine Grohar    773-702-0316    jgrohar@bsd.uchicago.edu   
Sponsors and Collaborators
Fibralign Corporation
University of Chicago
Stanford University
Investigators
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Principal Investigator: David W Chang, MD, FACS The University of Chicago Medicine & Biological Sciences
Study Director: Dung H Nguyen, MD, PharmD Stanford University
Study Director: Rebecca Garza, MD The University of Chicago Medicine & Biological Sciences
Publications:
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Responsible Party: Fibralign Corporation
ClinicalTrials.gov Identifier: NCT04606030    
Other Study ID Numbers: 5R44CA203608 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Fibralign Corporation:
Lymphedema
Edema
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases