Study on the feasibility of fluorescence bronchoscopy with bevacizumab-800CW - DEFLECT I

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

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-07-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

UMCG Cancer Research Foundation

External identifiers

EU CT number

2024-510793-24-00

ClinicalTrials.gov

NCT06809946

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To assess the feasibility of fluorescence molecular imaging with bevacizumab-800CW during bronchoscopy for identification of malignant pulmonary lesions and/or pathological lymph nodes.

Secondary objectives 3

1. To correlate and validate both the in vivo and ex vivo measured fluorescence signals with histopathological analysis
2. To determine the most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy
3. To assess safety of fluorescence molecular imaging after administration of bevacizumab-800CW

Conditions and MedDRA coding

suspected malignant pulmonary disease (lung lesions and/or lymph nodes suspicious for lung cancer)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Signed informed consent prior to participation in the study.
2. Age ≥ 18 years.
3. Patient has at least one intrabronchial, near-to-airway located or peripheral pulmonary nodule – with or without pathological lymph nodes – which is considered malignant (independent of its primary origin).
4. Patient is considered fit to undergo a diagnostic and/or therapeutic bronchoscopy (with or without addition of virtual navigation and/or endobronchial ultrasound; including propofol sedation or general anesthesia if either is indicated) to obtain tumor material according to standard care protocols.

Exclusion criteria 3

1. History of infusion reactions to bevacizumab or other monoclonal antibodies according to the patient’s medical history
2. Medical or psychiatric conditions that compromise the patient’s ability to give informed consent.
3. Pregnancy or breast feeding. A negative pregnancy test must be available for women of childbearing potential (i.e. premenopausal women with intact reproductive organs and women less than two years after menopause) on the day of tracer administration.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Comparison of the in vivo fluorescent signal of malignant lesion (pulmonary nodule or lymph node metastasis) versus non-tumorous tissue: The fluorescent signal will be assessed qualitatively (categorical data) and quantitatively (pulmonary nodule: by multi-diameter single fiber reflectance spectroscopy/single-fiber fluorescence spectroscopy (MDSFR/SFF), lymph node metastases: by ultrasound guided needle biopsy single-fiber fluorescence (USNB/SFF)).

Secondary endpoints 3

1. Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology result.
2. Most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy by assessment of in vivo tumor-to-background ratios.
3. Assessment of safety of bevacizumab-800CW injection and procedures in relation with fluorescent molecular imaging through summaries of adverse events, including data on the additional time (in minutes) needed for in vivo qualitative and quantitative assessment of the fluorescent signal. Adverse event data will be recorded and summarized according to NCI CTCAE v5.0.

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

Frederike Bensch

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Frederike Bensch

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 5 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