Fluorescence Guided Surgery in Breast Cancer

NCT02583568 | Completed Phase 1 DMC

• 1 other identifier: NL52447.042.15
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

A need for further investigation for fluorescence image-guided surgery in breast conserving surgery (BCS) has arisen following the results obtained from a phase I feasibility breast cancer trial (BIRDYE study: ABR NL 37479.042011). The aim of this study is to define the optimal dose of the fluorescent tracer Bevacizumab-IRDye800CW for intraoperative delineation of breast cancer tissue using the improved and optimized fluorescent tracer and camera system.

Conditions

Breast Cancer

Keywords

breast cancer; image-guided surgery

Outcome Measures

Primary Outcomes (1)

• Tumor-to-background ratio

  day 3

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events

  up to two weeks

Study Arms (2)

Part 1

EXPERIMENTAL

In part 1 a dose escalation will be performed for the tracer bevacizumab-800CW in four different dose groups (4,5mg 10mg 25mg 50mg)

Drug: Bevacizumab-800CW

Part 2

EXPERIMENTAL

In part 2, the two best performing dose groups of bevacizumab-800CW of part 1 will be expanded to a total of 10 patients per group.

Drug: Bevacizumab-800CW

Interventions

Bevacizumab-800CW DRUG

three days prior to surgery bevacizumab-800CW will be administered

Also known as: Bevacizumab-IRDye800CW

Part 1; Part 2

Eligibility Criteria

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

You may qualify if:

• Females aged ≥ 18 years.
• Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for breast cancer surgery.
• Tumor size ≥ 5 mm (0, 5 cm) diameter according to anatomical imaging data.
• WHO performance score 0-2.
• Life expectancy greater than 12 weeks
• Written informed consent has been obtained
• In the Investigator's opinion, patient is able and willing to comply with all trial requirements.
• For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:
• A negative serum pregnancy test prior to receiving the second generation tracer
• Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.

You may not qualify if:

• Medical or psychiatric conditions that compromise the patient's ability to give informed consent
• Breast prosthesis in the target breast
• History of infusion reactions to Bevacizumab or other monoclonal antibody therapies
• Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
• Significant renal or hepatic impairment.
• Inadequately controlled hypertension with or without current antihypertensive medications.
• History of myocardial infarction, transient ischemic attack, cerebro vascular accident, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment.
• Patients receiving anticoagulant therapy with vitamin K antagonists.
• Patients receiving Class IA (e.g. Quinidine) or Class III (e.g. Dofetilide, Amiodarone, Sotalol) antiarrhythmic agents.
• Evidence of QT prolongation on pre-treatment ECG (Males \>440 ms, Females \>450 ms).
• Magnesium, potassium and calcium levels below lower normal limit which is regarded clinically relevant with regards to study participation.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Martini Hospital Groningen: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie 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

• G.M van Dam, prof. dr.

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof.dr.

Study Record Dates

• First Submitted: June 30, 2015
• First Posted: October 22, 2015
• Study Start: October 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

NL (1)