Thyroid CarcinomaPhase 1TARGET-bevaNCT06095362
Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW
A Phase 1 study testing Bevacizumab-IRDye800CW in people with Thyroid Carcinoma and Surgery, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Background: Papillary thyroid cancer (PTC) patients often develop central lymph node metastases (CLNM), which pose a high risk of disease recurrence. The prophylactic central lymph node dissection (PCLND) is controversial, with proponents arguing for it to prevent local recurrence, and opponents objecting to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Carcinoma, Surgery
- What is being tested?
- Bevacizumab-IRDye800CW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 29 Nov 2021to 12 Oct 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Age ≥ 18 years, eligible for surgery
- Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC/FTC/HTC metastasis (primary or recurrence).
- Scheduled to undergo central and/or lateral lymph node dissection with or without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board.
- WHO performance score of 0-2.
- Written informed consent.
- Mentally competent person who is able and willing to comply with study procedures.
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- For female subjects who are of childbearing potential are premenopausal with intact reproductive organs or are less than two years post-menopausal:
- A negative serum pregnancy test prior to receiving the tracer
- Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.
Who cannot join
- Pregnancy or breast feeding
- Advanced stage thyroid cancer not suitable for surgical resection
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment
- The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months
- History of myocardial infarction (MI), TIA, CVA, pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment
- Any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thyroid Cancer and Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW With Molecular Fluorescence Guided Surgery. Thyroid cAncer Surgery With Intraoperative Molecular fluoRescent Imaging to rEduce overtreatmenT and Morbidity
Background: Papillary thyroid cancer (PTC) patients often develop central lymph node metastases (CLNM), which pose a high risk of disease recurrence. The prophylactic central lymph node dissection (PCLND) is controversial, with proponents arguing for it to prevent local recurrence, and opponents objecting to the hypoparathyroidism and nerve damage risk. Currently, no diagnostic tool exists to identify patients who would benefit from a PCLND. Molecular Fluorescence Guided Surgery (MFGS) is a potential solution that uses fluorescent tracers to detect cancerous tissue. This study aims to investigate whether the administration of a GMP-produced near infrared (NIR) tracer, bevacizumab-IRDye800CW, targeting VEGF-A, can enable intraoperative selection of PTC/FTC/HTC patients for CLND.
Objective: The primary objective of the study is to determine the optimal dose of bevacizumab-IRDye800CW for an adequate tumor-to-background ratio (TBR) in PTC/FTC/HTC lymph node metastases. The secondary objectives are to evaluate the feasibility of MFGS for PTC/FTC/HTC and nodal metastasis assessment, to correlate and validate fluorescence signals detected in vivo with ex vivo histopathology and immunohistochemistry, to evaluate the distribution of bevacizumab-IRDye800CW on a microscopic level, and to quantify the sensitivity and specificity of bevacizumab-IRDye800CW for PTC/FTC/HTC and nodal metastasis.
Read more
Study Design: The TARGET-BEVA study is a non-randomized, non-blinded, prospective, single-center phase I feasibility study for patients with confirmed PTC/FTC/HTC, for which the best TBR dosage group in PTC/FTC/HTC nodal metastasis will be determined. The study will initiate with a 3 x 3 scheme: 4,5 mg, 10 mg, and 25 mg, with three patients confirmed with lymph node metastasis in each group. Dosages will be based on previous studies, with the primary objective being the detection of lymph node metastasis. After the first 9 patients, an interim analysis will be performed, after which the best dosage group will be expanded with another 7 patients.
Conclusion: The study aims to identify a novel diagnostic tool that can aid clinicians in selecting patients for PCLND, enabling a reduction in overtreatment, morbidity, and costs while maintaining effectiveness with a lower recurrence rate and improved quality of life.
- Conditions
- Thyroid Carcinoma, Surgery
- Being tested
- Bevacizumab-IRDye800CW
- Keywords
- Optical Molecular Imaging, Molecular Fluorescence Guided Surgery
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab-IRDye800CWDrug
All patients will receive a dose of Bevacizumab-IRDye800CW, in a dose of 4.5, 10, or 25mg
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Drug: Bevacizumab-IRDye800CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescent signal levels defined as Tumor-to-Background Ratio (TBR) derived from PTC/FTC/HTC nodal metastasis and normal tissue to determine the optimal dose of Bevacizumab-800CW in patients with PTC/FTC/HTC
Measured: Whole study
Secondary outcomes (4)
Correlation of the fluorescent signal assessed by MFGS with other biological and molecular parameters (IHC) and the fluorescent signal assessed in the ex vivo biopsy specimens.
Measured: through study completion, an average of 2 years
Wound bed biopsy specimen characteristics (number of positive and negative biopsies.
Measured: through study completion, an average of 2 years
Distribution of bevacizumab-IRDye800CW in PTC/FTC/HTC, lymph nodes and normal tissue as identified by SDS-PAGE and/or ELISA and/or fluorescence microscopy.
Measured: through study completion, an average of 2 years
Quantification of sensitivity and specificity of Bevacizumab-800CW in order to make a power size calculation for a possible subsequent diagnostic accuracy study.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start29 Nov 2021
- Primary completion12 Oct 2023
- Study completion12 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CarcinomaStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095362
- Sponsor's protocol ID
- 202000846
- Acronym
- TARGET-beva
- Status last verified
- Aug 2024
- First submitted
- 10 Oct 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Cancer and Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW With Molecular Fluorescence Guided Surgery. Thyroid cAncer Surgery With Intraoperative Molecular fluoRescent Imaging to rEduce overtreatmenT and Morbidity
- ClinicalTrials.gov ID
- NCT06095362
- Acronym / sponsor ID
- TARGET-beva / 202000846
- Conditions
- Thyroid Carcinoma, Surgery
- Keywords
- Optical Molecular Imaging, Molecular Fluorescence Guided Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- 12 Oct 2023 (actual)
- Study completion
- 12 Oct 2023 (actual)
- First posted
- 23 Oct 2023 (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.
Background: Papillary thyroid cancer (PTC) patients often develop central lymph node metastases (CLNM), which pose a high risk of disease recurrence. The prophylactic central lymph node dissection (PCLND) is controversial, with proponents arguing for it to prevent local recurrence, and opponents objecting to the hypoparathyroidism and nerve damage risk. Currently, no diagnostic tool exists to identify patients who would benefit from a PCLND. Molecular Fluorescence Guided Surgery (MFGS) is a potential solution that uses fluorescent tracers to detect cancerous tissue. This study aims to investigate whether the administration of a GMP-produced near infrared (NIR) tracer, bevacizumab-IRDye800CW, targeting VEGF-A, can enable intraoperative selection of PTC/FTC/HTC patients for CLND.
Objective: The primary objective of the study is to determine the optimal dose of bevacizumab-IRDye800CW for an adequate tumor-to-background ratio (TBR) in PTC/FTC/HTC lymph node metastases. The secondary objectives are to evaluate the feasibility of MFGS for PTC/FTC/HTC and nodal metastasis assessment, to correlate and validate fluorescence signals detected in vivo with ex vivo histopathology and immunohistochemistry, to evaluate the distribution of bevacizumab-IRDye800CW on a microscopic level, and to quantify the sensitivity and specificity of bevacizumab-IRDye800CW for PTC/FTC/HTC and nodal metastasis.
Study Design: The TARGET-BEVA study is a non-randomized, non-blinded, prospective, single-center phase I feasibility study for patients with confirmed PTC/FTC/HTC, for which the best TBR dosage group in PTC/FTC/HTC nodal metastasis will be determined. The study will initiate with a 3 x 3 scheme: 4,5 mg, 10 mg, and 25 mg, with three patients confirmed with lymph node metastasis in each group. Dosages will be based on previous studies, with the primary objective being the detection of lymph node metastasis. After the first 9 patients, an interim analysis will be performed, after which the best dosage group will be expanded with another 7 patients.
Conclusion: The study aims to identify a novel diagnostic tool that can aid clinicians in selecting patients for PCLND, enabling a reduction in overtreatment, morbidity, and costs while maintaining effectiveness with a lower recurrence rate and improved quality of life.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Bevacizumab-IRDye800CW |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years, eligible for surgery
- Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC/FTC/HTC metastasis (primary or recurrence).
- Scheduled to undergo central and/or lateral lymph node dissection with or without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board.
- WHO performance score of 0-2.
- Written informed consent.
Key exclusion criteria (7 listed)
- Pregnancy or breast feeding
- Advanced stage thyroid cancer not suitable for surgical resection
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment
- The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months
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 |
|---|---|---|
| Bevacizumab-IRDye800CWAll patients will receive a dose of Bevacizumab-IRDye800CW, in a dose of 4.5, 10, or 25mg | Drug | Intervention group |
Primary outcome
Fluorescent signal levels defined as Tumor-to-Background Ratio (TBR) derived from PTC/FTC/HTC nodal metastasis and normal tissue to determine the optimal dose of Bevacizumab-800CW in patients with PTC/FTC/HTC
Time frame: Whole study
4 secondary outcomes
Correlation of the fluorescent signal assessed by MFGS with other biological and molecular parameters (IHC) and the fluorescent signal assessed in the ex vivo biopsy specimens.
Time frame: through study completion, an average of 2 years
Wound bed biopsy specimen characteristics (number of positive and negative biopsies.
Time frame: through study completion, an average of 2 years
Distribution of bevacizumab-IRDye800CW in PTC/FTC/HTC, lymph nodes and normal tissue as identified by SDS-PAGE and/or ELISA and/or fluorescence microscopy.
Time frame: through study completion, an average of 2 years
Quantification of sensitivity and specificity of Bevacizumab-800CW in order to make a power size calculation for a possible subsequent diagnostic accuracy study.
Time frame: through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Optical Molecular Imaging Group GroningenLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bevacizumab-IRDye800CW in people with Thyroid Carcinoma and Surgery, 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 9 inclusion and 7 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: finished, as of the sponsor's last update on 22 Aug 2024. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescent signal levels defined as Tumor-to-Background Ratio (TBR) derived from PTC/FTC/HTC nodal metastasis and normal tissue to determine the optimal dose of Bevacizumab-800CW in patients with PTC/FTC/HTC (time frame: Whole study). 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 22 Aug 2024.