Breast Cancer Breast Cancer
Conditions
Interventions
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part A1. Subject is 18-55 years old at screening (inclusive). 2. Subject is able and willing to comply with study procedures. 3. Subject is in good general health, according to the investigator’s judgement based on vital signs, medical history, physical examination, and laboratory tests performed. 4. Subject has a body mass index between 18-32 kg/m2 (inclusive) and with a minimum body weight of 50 kg at screening. 5. Subject needs to be surgically sterile, post-menopausal or pre-menopausal with a negative urine pregnancy test at screening and before administration of 6QC-ICG. Premenopausal subjects who are not surgically sterile have to agree to use an effective method of contraception. 6. Subject’s screening ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered to be clinically insignificant. 7. Subject has negative test results for drug and alcohol screening. 8. Subject has sufficient application area of healthy intact skin of the back (>100 cm2). 9. Written informed consent must be given prior to any study activities, according to ICH/GCP and national/local regulations. Part B Patient is 18 years of age or older at screening. Patient is able and willing to comply with study procedures. Patient is diagnosed with biopsy confirmed, Bloom-Richardson grade 3 invasive breast cancer and/or grade 3 ductal carcinoma in situ (DCIS) and is scheduled to undergo breast-conserving surgery at the Leiden University Medical Center or Haaglanden Medical Center. Patient has a 12-lead ECG and clinical laboratory test results that are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the investigator. Patient needs to be surgically sterile, post-menopausal or pre-menopausal with a negative urine pregnancy test before administration of 6QC-ICG. Premenopausal patients who are not surgically sterile have to agree to use an effective method of contraception for at least 30 days after their last dose of study treatment. Written informed consent must be given prior to any study activities, according to ICH/GCP and national/local regulations.
Exclusion criteria
Exclusion criteria: Part A1. (A history of) any clinically significant medical condition or abnormalities, as judged by the investigator, in physical examination, laboratory test results (including chemistry panel with hepatic and renal panels, complete blood count, and urine dipstick) or electrocardiography (ECG) at screening. In the case of uncertain or questionable results, tests performed during screening may be repeated to confirm eligibility or judged by the investigator to be clinically irrelevant for healthy subjects. 2. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments. 3. Subject has presence of any tattoos, scratches, open sores, excessive hair, or skin damages in the target treatment area(s) that, in the opinion of the investigator, may interfere with study evaluations. 4. Subject has a Fitzpatrick’s Skin Phototype =4. 5. Subject has had excessive sun exposure, is planning a trip to a sunny climate, or has used tanning booths within 4 weeks prior to Day 1 or is not willing to minimize natural and artificial sunlight exposure during the study. Use of sunscreen products (except on application areas) and protective apparel are recommended when sun exposure cannot be avoided.6. Subject has received laser treatment, electrolysis on the application areas within 4 weeks prior to Day 1 or is planning to during the study period. 7. Subject has shaved the application area 72 hours prior to Day 1 or is planning to do so during the study period. 8. Subject has used a topical applied treatment on the targeted application area(s) within 1 week prior to Day 1. 9. Subject has a history of hypertrophic scarring or keloid formation in scars or suture sites. 10. Subject has taken anticoagulant medication, such as heparin, low molecular weight (LMW)-heparin, warfarin, antiplatelets (except low-dose aspirin =81 mg which will be allowed), 11. within 2 weeks prior to Day 1, or has a contraindication to skin biopsies. 12. Subjects that are lactating or pregnant. 13. The subject has a positive screening test for hepatitis B, hepatitis C, or human immunodeficiency virus. 14. Use of any prescription medication and any other substance that in the opinion of the investigators may influence the outcome of the study within 7 days prior to study drug administrations, or less than five half-lives (whichever is longer, and during the course of the study). 15. Previous inclusion in this study. 16. Participation in a clinical trial within 3 months or 5 half-lives (if half-life is known), whichever is longer. 17. Use of alcohol during the 24 hours prior to screening and/or an unwillingness to abstain from alcohol consumption during the stay at the clinical unit, and for at least 24 hours prior to each study visit; 18. Positive urine drug screen or alcohol test at screening and/or at first study day. 19. History of anaphylactic reactions to a prescription drug, over-the-counter drug, or herbal supplement. 20. Loss or donation of blood over 500 mL within four months prior to screening. 21. Any other condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of local tolerabilityLIGS scoreNumerical rating of pain and itch scalesLocal treatment-induced (serious) adverse events ((S)AEs)Systemic treatment-induced (serious) adverse events ((S)AEs) throughout the studyVital signs (HR [bpm], systolic blood pressure [mmHg], diastolic blood pressure [mmHg]) according to the assessment scheduleClinical laboratory tests (hematology, blood chemistry, and urinalysis) according to the assessment scheduleECG parameters (heart rate [HR] [bpm], PR, QRS, QT, QTcF) according to the assessment scheduleConcomittant medication | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of 6qc-ICG via multicompartmental analysis of plasma concentration–time data and urine data:AUCinf, AUClast, CL/F, Cmax, t½, tlag, tmax, Vz/FDose-normalized PK parameters: AUCinf, AUClast, CmaxUrine PK parameters: Aelast, Aelast%, CLRStatus of wound healing over timeAnalysis of NIR fluorescence images of all walls of the surgical cavity:Fluorescence: yes or noTumor present in biopsy from fluorescent area: yes or noNo tumor-positive margins on pathology at the location of fluorescent-negative cavity walls: yes or noSignal-to-background ratio (SBR) of the fluorescent area | — |
Countries
Netherlands
Contacts
Public ContactC.M.W. Pesch
Leids Universitair Medisch Centrum
Outcome results
None listed