Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Fibralign Corporation

Collaborator: University of Chicago

Stanford Investigator(s):

Intervention(s):

  • Device: BioBridge® Collagen Matrix
  • Procedure: Vascularized Lymph Node Transfer (VLNT)

Phase:

N/A

Eligibility


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.

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Dung H Nguyen, MD, PharmD
Not Recruiting