Study on the effect of 6qc-ICG on the skin of healthy volunteers and in patients with breast cancer during surgeries.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Phenomena and Processes [G] - Physiological processes [G07]

Decision date (initial)

2025-12-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

National Institution of Health (NIH)

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Pharmacokinetic, Efficacy, Safety

Part A; To assess the local and systemic safety and tolerability of a single-dose of topically applied 6qc-ICG on wounded skin of healthy volunteers.
Part B; To assess the local and systemic safety and tolerability of a single-dose of topically applied 6qc-ICG for intraoperative visualization of (residual) breast cancer in patients undergoing breast conserving surgery

Secondary objectives 5

1. To perform pharmacokinetic analyses of blood
2. To assess wound healing with 6qc-ICG following single-dose topical application on wounded skin
3. To determine if a single-dose of topically applied 6qc-ICG enables detection of residual cancer in the surgical cavity after BCS using NIR fluorescence
4. To determine the fluorescence intensities in the (residual) tumor tissue
5. Calculate sensitivity and specificity compared to standard histopathology

Conditions and MedDRA coding

Breast cancer

Regulatory references

Scientific advice from competent authorities

Leids Universitair Medisch Centrum (LUMC)

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 13

1. Subject is 18-55 years old at screening (inclusive) (part A).
2. Subject is able and willing to comply with study procedures (part A and B).
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 (part A).
4. Subject has a body mass index between 18-32 kg/m2 (inclusive) and with a minimum body weight of 50 kg at screening (part A)
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 (part A)
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 (part A).
7. Subject has negative test results for drug and alcohol screening. (part A)
8. Subject has sufficient application area of healthy intact skin of the back (>100 cm2). (part A)
9. Written informed consent must be given prior to any study activities, according to ICH/GCP and national/local regulations. (part A and B)
10. Patient is 18 years of age or older at screening. (part B)
11. 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.. (part B)
12. 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. (part B)
13. 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. (part B)

Exclusion criteria 30

1. (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. (part A)
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. (part A)
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. (part A)
4. Subject has a Fitzpatrick’s Skin Phototype ≥4. (part A)
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. (part A)
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. (part A)
7. Subject has shaved the application area 72 hours prior to Day 1 or is planning to do so during the study period. (part A)
8. Subject has used a topically applied treatment on the targeted application area(s) within 1 week prior to Day 1. (part A)
9. Subject has a history of hypertrophic scarring or keloid formation in scars or suture sites. (part A)
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), within 2 weeks prior to Day 1, or has a contraindication to skin biopsies. (part A)
11. Subjects that are lactating or pregnant. (part A)
12. The subject has a positive screening test for hepatitis B, hepatitis C, or human immunodeficiency virus. (part A)
13. 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). (part A)
14. Previous inclusion in this study. (part A)
15. Participation in a clinical trial within 3 months or 5 half-lives (if half-life is known), whichever is longer. (part A)
16. 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; (part A)
17. Positive urine drug screen or alcohol test at screening and/or at first study day. (part A)
18. History of anaphylactic reactions to a prescription drug, over-the-counter drug, or herbal supplement. (part A)
19. Loss or donation of blood over 500 mL within four months prior to screening. (part A)
20. Any other condition that in the opinion of the investigator would complicate or compromise the study or the well-being of the subject. (part A)
21. Patient has a radiologic complete response of the primary tumor (rCR) after neoadjuvant therapy. (part B)
22. Patient has a history of surgery and/or radiation on the ipsilateral breast. (part B)
23. Patient has a history of clinically significant allergies or anaphylactic reactions. (part B)
24. Patient has any condition that in the opinion of the investigators could potentially jeopardize the patient’s well-being or the study objectives. (part B)
25. Patient has hyperthyroidism defined as TSH < 0.15 mU/l and free T4 > 24.0 pmol/l. (part B)
26. Patient has an impaired renal function defined as eGFR<50 ml/min/1.73m2. (part B)
27. Patient has an impaired liver function defined as values greater than 3x the upper limit of normal (ULN) for ALT, AST, or 2x the upper limit of normal for total bilirubin (part B)
28. Patient participates in another clinical trial for which the patient receives a fluorophore perioperatively. (part B)
29. Patient is lactating or pregnant. (part B)
30. Patient has any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. (part B)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 9

1. Local tolerability assessment
2. LIGS score
3. Numeric rating scales pain and pruritus
4. Local treatment-emergent (serious) adverse events ((S)AEs)
5. Systemic treatment-emergent (serious) adverse events ((S)AEs) throughout the study
6. Vital signs (pulse rate (bpm), systolic blood pressure (mmHg), diastolic blood pressure (mmHg)) as per assessment schedule
7. Clinical laboratory tests (hematology, blood chemistry and urinalysis) as per assessment schedule
8. ECG parameters (heart rate (HR) (bpm), PR, QRS, QT, QTcF) as per assessment schedule
9. Concomitant medication

Secondary endpoints 3

1. PK- parameters of 6qc-ICG by multi-compartmental analysis of the plasma concentration-time data and urine data: o AUCinf, AUClast, CL/F, Cmax, t1/2, tlag, tmax, Vz/F o Dose-normalized PK parameters: AUCinf, AUClast, Cmax o Urine PK parameters: Aelast, Aelast%, CLR
2. Status of wound closure over time
3. Analysis of NIR fluorescence images of all the surgical cavity walls: o Fluorescent yes or no o Tumor in biopsy of fluorescent area yes or no o No tumor-positive margins at pathology at the location of fluorescent-negative cavity walls yes or no o Signal-to-background ratio (SBR) of fluorescent area

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Leids Universitair Medisch Centrum (LUMC)

Sponsor organisation

Leids Universitair Medisch Centrum (LUMC)

Address

Albinusdreef 2

City

Leiden

Postcode

2333 ZA

Country

Netherlands

Scientific contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Cedric Pesch

Public contact point

Organisation

Leids Universitair Medisch Centrum (LUMC)

Contact name

Cedric Pesch

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications