Targeted fluorescence endoscopy for detection of the primary cancer lesion in patients with a metastasis of unknown primary tumor in the head and neck

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04], Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-11-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513897-23-00

EudraCT number

2018-001885-41

ClinicalTrials.gov

NCT06100081

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To study the feasibility of identifying primary tumors in the upper aerodigestive tract in patients with unknown primary cancer with the use of targeted fluorescence endoscopy with cetuximab-800CW as the fluorescent tracer

Secondary objectives 7

1. To obtain information on safety aspects of cetuximab-800CW administration by registration of side effects, adverse events (AE), serious adverse events (SAE) and suspected unexpected serious adverse reactions (SUSAR)
2. To determine the feasibility of flexible fluorescence laryngoscopy at the outpatient clinic for primary tumor detection using TFE
3. To quantify intrinsic fluorescence signals of cetuximab-800CW
4. To determine if ex vivo fluorescence imaging using cetuximab-800CW can be used for assessment of the surgical specimen after mucosectomy
5. To determine the specificity and positive predictive value of TFE and WLE for the detection of the primary tumor in patients with CUP
6. To correlate and validate fluorescence signals in vivo and ex vivo with histopathology
7. To study health-related quality of life data regarding the standard of care mucosectomy procedures performed with transoral robot surgery

Conditions and MedDRA coding

Unknown primary tumour of the head and neck

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Cytology and/or histology-confirmed diagnosis of squamous cell carcinoma most likely originating from the head & neck area and scheduled to undergo endoscopy of the upper aerodigestive tract as decided by the multidisciplinary head and neck tumor board of the UMCG
2. The primary tumor was not identified during standard diagnostic work-up in the outpatient clinic including physical head and neck examination, fiberoptic laryngoscopy, chest X-ray, CT and PET/CT
3. Age ≥ 18 years
4. Written informed consent

Exclusion criteria 11

1. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent
2. Concurrent uncontrolled medical conditions
3. Received an investigational drug within 30 days prior to the dose of cetuximab-800CW
4. History of myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease (ALT >3X upper limits of normal or increased total bilirubin) or unstable angina within 6 months prior to enrollment
5. Inadequately controlled hypertension with or without current antihypertensive medications
6. History of allergy or infusion reactions cetuximab or other monoclonal antibody therapies
7. Pregnant or lactating women. Documentation of a negative pregnancy test must be available for women of childbearing potential. Moreover, the need to be willing to ensure that she or her partner uses effective contraception during the trial and for 6 months thereafter. Woman of childbearing potential are premenopausal women with intact reproductive organs and women less than two years after menopause
8. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
9. Patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
10. Life expectancy < 12 weeks
11. Karnofsky performance status < 70%

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Macroscopic fluorescent signal levels and tracer distribution observed with TFE
2. Detection rates of TFE and WLE

Secondary endpoints 6

1. Patient characteristics (age, sex, BMI, history and morbidity, localization of primary tumor and lymph node metastasis, vital parameters and presence of symptoms before and after tracer administration)
2. Macroscopic fluorescent signal levels and tracer distribution observed with flexible fluorescence laryngoscopy
3. Quantification of intrinsic fluorescence signals observed using the MDSFR/SFF probe
4. Macroscopic fluorescent signal levels and tracer distribution observed with ex vivo imaging of FSA and mucosectomy specimens
5. Histopathologic characteristics of biopsied specimens including HPV-status
6. Results of the quality of life questionnaires QLQ-C30, QLQH&N35 and SWAL-QOL

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Max Witjes

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Max Witjes

Locations

1 EU/EEA country · 1 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 4 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