Validation of ICG-99mTc-nanoscan as hybrid tracer for sentinel node biopsy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

15 Nov 2023 → ongoing

Decision date (initial)

2024-12-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-519351-28-00

EudraCT number

2022-003297-24

ClinicalTrials.gov

NCT06666634

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.

Secondary objectives 2

1. Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan);
2. Concordance between intraoperative fluorescence and radioactive findings, using:  Number and intensity of the fluorescent nodes at time of excision;  Number and radioactive signal intensity of the radioactive nodes at time of excision;

Conditions and MedDRA coding

Patients with melanoma of the head/neck or the upper part of the trunk, oral malignancies or penile carcinoma who are scheduled for a sentinel node (SN) biopsy.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patient who will undergo a sentinel node procedure in routine care.
2. Patients > 18 years;
3. Patients presenting with:  a primary cutaneous melanoma of head/neck or upper part of the trunk or extremities;  OR patients presenting with a primary oral cavity malignancy T1-2N0  OR patients with primary penile cancer
4. Patients with clinical N0 stage;
5. Patients scheduled for a sentinel node biopsy prior to (re-)excision of the primary lesion
6. Patients in which ICG-99mTc-nanoscan would be used in routine care or a research setting.

Exclusion criteria 7

1. Patients with known allergy to patent blue dye
2. Patients who are pregnant or breast-feeding mothers
3. History of hypersensitivity reactions to products containing human serum albumin
4. History of iodine allergy
5. Hyperthyroid or thyroidal adenoma
6. Kidney insufficiency
7. Incapacity or unwillingness of participant to give written informed consent;

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To demonstrate concordance between the SN visualization of 99mTc-nanoscan and ICG-99mTc-nanoscan on preoperative lymphoscintigraphy and SPECT/CT imaging, expecting an average of 3 sentinel nodes per patient. Discordance is defined as more than 1 sentinel node not detected coherently by the tracers.

Secondary endpoints 2

1. Number of higher-echelon nodes visualized on preoperative lymphoscintigraphy and SPECT/CT imaging for both tracers (ICG-99mTc-Nanoscan and 99mTc-Nanoscan); 99mTc-Nanoscan is used as reference tracer.
2. Concordance between intraoperative fluorescence and radioactive findings, using:  Number and intensity of the fluorescent nodes at time of excision;  Number and radioactive signal intensity of the radioactive nodes at time of excision

Investigational products

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

Test 2

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Sponsor organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Address

Plesmanlaan 121

City

Amsterdam

Postcode

1066 CX

Country

Netherlands

Scientific contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Dr. O. Brouwer

Public contact point

Organisation

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Contact name

Dr. O. Brouwer

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 6 files

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

Application history

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