Lung NeoplasmsPhase 2DEFLECT INCT06809946
Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy
A Phase 2 study testing injection with 15 mg bevacizumab-800CW before bronchoscopy and injection with 25 mg bevacizumab-800CW before bronchoscopy in people with Lung Neoplasms and Pulmonary Neoplasms, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
In this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (NIRF) tracer bevacizumab-800CW for assessment of pulmonary lesions and/or lymph nodes considered to be malignant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms, Pulmonary Neoplasms, Lymph Node Involvement
- What is being tested?
- injection with 15 mg bevacizumab-800CW before bronchoscopy and injection with 25 mg bevacizumab-800CW before bronchoscopy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 17 Aug 2026to 17 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to participation in the study.
- Age ≥ 18 years.
- 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).
- 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.
Who cannot join
- History of infusion reactions to bevacizumab.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Pregnancy or breast feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
University Medical Center Groningen
Groningen
Frederike Bensch, MD, PhD, f.bensch@umcg.nl
About this study
Official title: Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy in Patients With a Pulmonary Lesion Considered to be Malignant - DEFLECT I
In this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (NIRF) tracer bevacizumab-800CW for assessment of pulmonary lesions and/or lymph nodes considered to be malignant.
- Being tested
- injection with 15 mg bevacizumab-800CW before bronchoscopy, injection with 25 mg bevacizumab-800CW before bronchoscopy
- Keywords
- Fluorescence molecular bronchoscopy, Bevacizumab-800CW, Near-infrared fluorescence imaging, Molecular imaging, Pulmonary nodule
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection with 15 mg bevacizumab-800CW before bronchoscopyDrug
Patients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.
injection with 25 mg bevacizumab-800CW before bronchoscopyDrug
Patients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo.
| Study group | Role | What they receive |
|---|---|---|
| Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 15 mg | Experimental | Not described Receives: Drug: injection with 15 mg bevacizumab-800CW before bronchoscopy |
| Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 25 mg | Experimental | Not described Receives: Drug: injection with 25 mg bevacizumab-800CW before bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescent signal of malignant lesion versus non-tumorous tissue.
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)).
Measured: Assessed directly during the bronchoscopy procedure
Secondary outcomes (3)
FLuorescence signal analyses
Correlation of the fluorescence signals detected in vivo and ex vivo, with histopathology/cytology results.
Measured: Up to 1 year
Optimal dose of bevacizumab-800CW
Most optimal dose of bevacizumab-800CW for fluorescence molecular bronchoscopy by assessment of in vivo tumor-to-background ratios.
Measured: Up to 1 year
Safety of bevacizumab-800CW injection and fluorescence molecular imaging
Assessment of safety of bevacizumab-800CW injection and procedures in relation with fluorescence 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.
Measured: Up to 24 hours after the fluorescence molecular bronchoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start17 Aug 2026 (estimated)
- Primary completion17 Aug 2028 (estimated)
- Study completion17 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809946
- Sponsor's protocol ID
- 202100285
- Other IDs
- 2024-510793-24-00
- Acronym
- DEFLECT I
- Status last verified
- Mar 2026
- First submitted
- 30 Jan 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Fluorescence Imaging With Bevacizumab-800CW During Bronchoscopy in Patients With a Pulmonary Lesion Considered to be Malignant - DEFLECT I
- ClinicalTrials.gov ID
- NCT06809946
- Acronym / sponsor ID
- DEFLECT I / 202100285
- Keywords
- Fluorescence molecular bronchoscopy, Bevacizumab-800CW, Near-infrared fluorescence imaging, Molecular imaging, Pulmonary nodule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 17 Aug 2026 (estimated)
- Primary completion
- 17 Aug 2028 (estimated)
- Study completion
- 17 Aug 2028 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this feasibility study, bronchoscopy will be combined with fluorescence molecular imaging using the near-infrared fluorescence (NIRF) tracer bevacizumab-800CW for assessment of pulmonary lesions and/or lymph nodes considered to be malignant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 15 mg | Experimental | Drug: injection with 15 mg bevacizumab-800CW before bronchoscopy |
| Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 25 mg | Experimental | Drug: injection with 25 mg bevacizumab-800CW before bronchoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent prior to participation in the study.
- Age ≥ 18 years.
- 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).
- 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.
Key exclusion criteria (3 listed)
- History of infusion reactions to bevacizumab.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent.
- Pregnancy or breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection with 15 mg bevacizumab-800CW before bronchoscopyPatients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo. | Drug | Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 15 mg |
| injection with 25 mg bevacizumab-800CW before bronchoscopyPatients will receive an intravenous administration of 15 mg bevacizumab-800CW before the bronchoscopy procedure. The bronchoscopy will start with high-definition white light bronchoscopy, followed by fluorescence molecular bronchoscoy to observe the fluorescence signal and MDSFR-SFF spectroscopy to quantify the fluores-cence signal in vivo. | Drug | Fluorescence molecular imaging during bronchoscopy with bevacizumab-800CW at dose of 25 mg |
Primary outcome
Fluorescent signal of malignant lesion versus non-tumorous tissue.
Time frame: Assessed directly during the bronchoscopy procedure
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)).
3 secondary outcomes
FLuorescence signal analyses
Time frame: Up to 1 year
Optimal dose of bevacizumab-800CW
Time frame: Up to 1 year
Safety of bevacizumab-800CW injection and fluorescence molecular imaging
Time frame: Up to 24 hours after the fluorescence molecular bronchoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing injection with 15 mg bevacizumab-800CW before bronchoscopy and injection with 25 mg bevacizumab-800CW before bronchoscopy in people with Lung Neoplasms and Pulmonary Neoplasms, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederike Bensch, MD, PhD (0031503610280, f.bensch@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescent signal of malignant lesion versus non-tumorous tissue. (time frame: Assessed directly during the bronchoscopy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.