Guided by Light: Optimizing Surgical Excision of Oral Cancer Using Realtime Fluorescence Imaging

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2024-12-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

KWF Kanker Bestrijding

External identifiers

EU CT number

2024-512824-13-01

EudraCT number

2019-003416-30

ClinicalTrials.gov

NCT04191460

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Safety

To improve adequate resection of oral cancer using fluorescent imaging
technology:
1. To determine the recommended dose for the highest tumor-tobackground
ratio (TBR) of at least >1.5 using cRGD-ZW800-1 in oral cancer;
2. To increase the rate of adequate (i.e. >5mm clear) tumor resection margins

Secondary objectives 6

1. To determine the recommended dosage of cRGD-ZW800-1 for intraoperative imaging of oral cancer.
2. To determine the sensitivity, specificity, positive and negative predictive values of FLI
3. To-determine colocalization of FLI with immunochemistry on pathology slides
4. To determine the percentage of extra tissue resection based on FLIdriven frozen sections
5. To determine if FLI significantly increases operation time
6. To determine if lymph node metastases can be identified using FLI

Conditions and MedDRA coding

Oral cancer

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients with biopsy-proven squamous cell carcinoma of the oral cavity, eligible for surgical resection of the primary tumor;
2. Patients ≥ 18 years of age;
3. Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion criteria 8

1. Previous surgery, chemotherapy or radiotherapy to the oral cavity;
2. History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent.
3. Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductive potential;
4. Patients with renal insufficiency (eGFR<60);
5. Patients with a previous kidney transplantation in the medical history;
6. Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2 inhibitors);
7. Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impaired on weakened immune system, caused by either a pre-existing disease or concomitant medications;
8. Any condition that the investigator, anesthesiologist or head- and neck surgeon considers to be potentially jeopardizing the patient's wellbeing or the study objectives.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of adequate (i.e. >5mm clear) tumor resection margins.

Secondary endpoints 5

1. Sensitivity, specificity, positive and negative predictive values
2. Co-localization of FLI with immunohistochemistry on pathology slides
3. Percentage of extra tissue resection based on FLI-driven frozen sections
4. Operation time
5. FLI of lymph node metastases after neck dissection

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Sponsor organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Address

Dr. Molewaterplein 40

City

Rotterdam

Postcode

3015 GD

Country

Netherlands

Scientific contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Stijn Keereweer

Public contact point

Organisation

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Contact name

Stijn Keereweer

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 3 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