Is it possible to make breast cancer visible during surgery by using a fluorescent tumor-specific dye during breast cancer surgery?

• Conditions: Patients with breast cancer eligible for surgery; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-000535-33-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-29
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male or Female, aged = 18 years.
2.Confirmed diagnosis of breast cancer by means of histology or cytology and eligible for tumor resection surgery.
3.Tumor size = 5 mm (0, 5 cm) diameter according to anatomical imaging data.
4.WHO performance score 0-2.
5.Life expectancy greater than 12 weeks
6.Written informed consent has been obtained
7.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
8.A negative serum pregnancy test within 2 weeks prior to receiving the second generation tracer
9.Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 27

Exclusion Criteria

1.Non palpable breast tumor
2.Breast prosthesis in the target breast
3.History of infusion reactions to Bevacizumab or other monocolonal antibody therapies
4.Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last 6 weeks prior to the start of the treatment
5.Unresolved chronic non-hematological toxicity higher than NCI-CTC grade 2
6.Participation in a clinical study involving an investigational drug or device within 30 days prior to the start of treatment
7.Significant renal or hepatic impairment.
8.Scheduled elective surgery, with the exception of the breast surgical procedure, or other procedures requiring general anaesthesia during the trial.
9.Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
10.Inadequately controlled hypertension with or without current antihypertensive medications.
11.History of MI, TIA, CVA, pulmonary embolism, uncontrolled CHF, significant liver disease, unstable angina within 6 months prior to enrolment.
12.Patients receiving anticoagulant therapy with vitamin K antagonists.
13.Patients receiving Class IA or Class III antiarrhythmic agents.
14.Evidence of QT prolongation on pre treatment ECG (males >440ms, females>450 ms)
15.Magnesium, potassium and calcium levels below LLN which is regarded clinically relevant with regards to study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified