VEGF-targeted Fluorescent Tracer Imaging in Breast Cancer

NCT01508572 | Completed Phase 1 DMC

• 2 other identifiers: UMCG/UMCU_012011-003083-75
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the uptake, (semi-)quantification and localization of the VEGF targeting fluorescent tracer bevacizumab-IDRye800CW in breast cancer tissue, surrounding healthy tissue, tumor margins and lymph nodes. This is measured in surgical specimens after a single intravenous administration of 4,5 bevacizumab-IDRye800CW, using fluorescence microscopy and macroscopy techniques. Also the safety of bevacizumab-IDRye800CW is assessed. Another purpose is to assess the abilities of three different fluorescent signal detection systems to detect the fluorescent signal pre- and intra-operatively.

Conditions

Breast Cancer

Keywords

breast cancer; VEGF; optical imaging

Outcome Measures

Primary Outcomes (2)

• The uptake of bevacizumab-IRDye800CW in breast cancer tissue, surrounding tissue and lymph nodes in surgical specimens by fluorescence microscopy and macroscopy

  Outcome measures: * The accumulation, tissue distribution, lokalization and (semi) quantification of bevacizumab-IRDye800CW in breast cancer tissue, surrounding tissue and lymph nodes. Measured by macroscopy using MSOT, Odessey and MFRI and by microscopy using fluorescence microscope and Odessey. * Correlation of the above to VEGF-levels and other biological parameters.

  After the last patient is included, which is expected to be within one year after the first inclusion

• Occurrence of adverse events as a measure of safety and tolerability of bevacizumab-IRDye800CW

  Obtaining information on safety aspects of bevacizumab-IRDye 800CW, side effects, AE, SAE, SUSAR by observing patients after tracer injection and follow up until 14 days after surgery

  Participants will be observed for the duration of hospital stay, an expected average of 4 hours after tracer injection. In case of adverse events, patients are observed and treated until recovery

Secondary Outcomes (3)

• Detection ability of preoperative optical fluorescence imaging techniques (FDOT; Fluorescence diffuse optical tomography and MSOT; multispectral opto-acoustic imaging) of the fluorescent signal from bevacizumab-IRDye800CW

  detection of the tracer is performed at 4h, 36h and 72h after tracer injection.

• Detection ability of the intra-operative mulitspectral fluorescence reflectance imaging (MFRI) of the fluorescent signal from bevacizumab-IRDye 800CW during surgery

  72 hours after tracter injection, during surgery.

• Detection ability of all optical imaging techniques (FDOT, MSOT, MFRI) of the fluorescent signal in surgical specimens ex vivo

  after the last patient is operated, which is approximately one year after study start.

Study Arms (1)

bevacizumab-IRDye800CW

EXPERIMENTAL

In this two stage, non-randomized, non-blinded, prospective, multicenter feasibility study, bevacizumab-IRDye800CW will be administered to a total of 20 patients with proven breast cancer.

Drug: bevacizumab-IRDye800CW

Interventions

bevacizumab-IRDye800CW DRUG

In this two stage, non-randomized, non-blinded, prospective, multicenter feasibility study, bevacizumab-IRDye800CW will be administered to a total of 20 patients with proven breast cancer.

Also known as: Fluorescence tracer imaging, Beva-800CW, Bevacizumab-800CW

bevacizumab-IRDye800CW

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Patients with proven breast cancer (cytology, histology) who are scheduled to receive operation intervention.
• Tumor size of at least 15 mm diameter according to anatomical imaging data.
• Signed written informed consent.
• Able to comply with the protocol.
• WHO performance score 0-2.

You may not qualify if:

• Other invasive malignancy.
• Serious other medical conditions.
• Pregnant or lactating women. (Documentation of a negative pregnancy test must be available for pre-menopausal women with intact reproductive organs and for women less than two years after menopause).
• Prior radiotherapy on the involved area.
• Major surgery within 28 days before the initiation of the study.
• Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
• Prior neo-adjuvant chemotherapy.
• Breast prosthesis in target breast.
• Breast is too big to fit in the biggest cup or is too small to fit in the smallest cup of the FDOT system.
• Non-intact skin at time of the FDOT procedures.
• Breast located skin diseases.
• Piercings or tattoos located on the breast/nipple.
• Contra-indication for MR procedures or claustrophobia.
• Inability to lay prone positioned for the duration of the FDOT procedure (10 minutes) and MR procedure (30 minutes).
• Tumor located close to the chest wall as assessed by breast imaging data.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• UMC Utrecht: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Go M. van Dam, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: January 12, 2012
• Study Start: October 1, 2011
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

NL (1)