Breast CancerPhase 2DoT-FMINCT05359874
Improvement of the Operative Outcome in Patients With Primary VEGF + Unifocal Breast Cancer or DCIS Through the Intraoperative Visualization of the Tumor Using Molecular Imaging and Bevacizumab-IRDye-800CW
A Phase 2 study testing Bevacizumab-IRDye800CW in people with Breast Cancer, run by Technical University of Munich.
Trial summary
It is a prospective, open, non-randomized, multicenter, one-armed, blinded (surgeon), diagnostic clinical trial according to AMG and MPG. The fluorescent marker Bevacizumab-IRDye800CW has advantages over conventional methods of tumor imaging in terms of accuracy, patient safety and validity. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bevacizumab-IRDye800CW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Mar 2023
- Phase
- Phase 2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women of age ≥ 18 years able to give consent who have been informed in detail about the study beforehand and have given written consent to participate
- Patients with histologically confirmed unifocal VEGF-positive invasive breast cancer with an indication for BET
- Patients with histologically confirmed unilateral VEGF-positive DCIS with an indication for BET
- ECOG performance ≤ 2
- Pre-menopausal women had a negative pregnancy test prior to administration of the study medication
- Negative pregnancy test (serum) within 10 days prior to administration of the test medication in all women of childbearing age with results available prior to the start of therapy (or postmenopausal; age ≥60 and no menses over ≥ 1 year without any other medical cause; or hysterectomy, or tube ligation, or bilaterally guided occlusion). Women of childbearing potential who are sexually active must agree that they and their partner may use effective contraception during the trial and for 3 months after participation
Who cannot join
- Second malignancy in the breast and other organs
- Pregnant or breastfeeding patients
- Planned sentinel lymph node marking using patent blue
- Previous radiation therapy in the area to be examined
- Known or suspected hypersensitivity to the study medication (according to IMPD / SmPC) or other immunoglobulins
- Currently after neoadjuvant (primarily systemic) chemotherapy and anti-hormone therapy
Show all 19Show fewer
- Immunotherapy (e.g. monoclonal antibodies, cytokines or signal transduction inhibitors) in the last 28 days prior to the declaration of consent
- Previous therapy with bevacizumab
- Planned reconstruction in the breast to be examined
- Previous surgery within the last 28 days prior to the declaration of consent
- Non-healing wounds, ulcers or broken bones within the last 28 days prior to giving informed consent
- Patients with ileus within the last 28 days prior to the declaration of consent
- Non-adjustable hypertension (> 145/90 mmHg) despite optimal drug therapy
- Insufficient kidney function (serum creatinine> 1.5 x upper limit of the normal range)
- Current or recent treatment with another investigational drug in another clinical trial within 28 days of informed consent
- Potentially fertile women without adequate contraception. Safe contraceptive measures are procedures with a Pearl index of ≤ 1%
- Patients with other serious illnesses that pose an unreasonable risk for participating in the study
- Persons who are in a dependent / employment relationship with the sponsor or investigator
- Persons who are to be or are to be accommodated in an institution due to a court or official order
About this study
Official title: Improvement of the Operative Outcome in Patients With Primary VEGF Positive Unifocal Breast Cancer or Ductal Carcinoma in Situ (DCIS) Through the Intraoperative Visualization of the Tumor Using Molecular Imaging and Fluorescent Markers Bevacizumab-IRDye-800CW
It is a prospective, open, non-randomized, multicenter, one-armed, blinded (surgeon), diagnostic clinical trial according to AMG and MPG. The fluorescent marker Bevacizumab-IRDye800CW has advantages over conventional methods of tumor imaging in terms of accuracy, patient safety and validity. In order to be able to detect this marker in vivo, special multispectral fluorescence-reflecting cameras (MFRI) were developed, which can be used for the intraoperative display of the tumor and potentially affected lymph nodes and which are now to be evaluated together with the fluorescence marker.
Read the detailed description
Complete surgical excision of the tumor (R0 resection) is the cornerstone of any curative therapy concept for cancer. In order to be able to achieve the highest possible rate of R0 resections, the tumor, its localization and spread needs to be more precisely represented. This should be possible through an intraoperative representation of the tumor by means of fluorescence imaging at the molecular level.
Vascular Endothelial Growth Factor (VEGF, or VEGF-A), which is expressed differently in normal and tumor tissue, is a suitable marker for molecular imaging, especially in gynecological cancer. Bevacizumab is a genetically engineered humanized monoclonal antibody that is directed against VEGF and is already therapeutically approved for the treatment of breast and ovarian cancer and has also shown efficacy in studies on endometrial cancer.
Fluorescence-labeled bevacizumab has advantages over conventional methods of tumor imaging in terms of accuracy, patient safety, cost efficiency and validity. A fluorescent marker, Bevacizumab-IRDye800CW, was developed and recently used in clinical trials in the Netherlands. In order to be able to detect this marker in vivo, special multispectral fluorescence-reflecting cameras (MFRI) were developed, which can be used for intraoperative visualization of the tumor and potentially affected lymph nodes. These systems can now be used to evaluate the fluorescent marker in clinical studies.
- Conditions
- Breast Cancer
- Being tested
- Bevacizumab-IRDye800CW
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab-IRDye800CWDrug
Also called Device: special multispectral fluorescence-reflecting cameras
In order to be able to detect this marker in vivo, special multispectral fluorescence-reflecting cameras (MFRI) were developed, which can be used for the intraoperative display of the tumor and potentially affected lymph nodes and which are now to be evaluated together with the fluorescence marker.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | Not described Receives: Drug: Bevacizumab-IRDye800CW |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the sensitivity and specificity of bevacizumab- IRDye800CW
Determination of the sensitivity and specificity of bevacizumab- IRDye800CW with regard to the identification of the tumor margins compared with the histopathological findings (resection result R0, R1) as the gold standard
Measured: 21 days
Secondary outcomes (1)
Safety and Toxicity of Bevacizumab-IRDye800CW will be analyzed by absolute and relative frequencies of Safety events
Absolute and relative frequencies of AE, SAE, AR, and SAR are presented by MedDRA System Organ Class and Preferred Term.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study startJun 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: application has been withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359874
- Sponsor's protocol ID
- DOT-1871-KIE-0120-I
- Acronym
- DoT-FMI
- Status last verified
- May 2021
- First submitted
- 14 May 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no patient specific data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of the Operative Outcome in Patients With Primary VEGF Positive Unifocal Breast Cancer or Ductal Carcinoma in Situ (DCIS) Through the Intraoperative Visualization of the Tumor Using Molecular Imaging and Fluorescent Markers Bevacizumab-IRDye-800CW
- ClinicalTrials.gov ID
- NCT05359874
- Acronym / sponsor ID
- DoT-FMI / DOT-1871-KIE-0120-I
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: application has been withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 4 May 2022 (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.
It is a prospective, open, non-randomized, multicenter, one-armed, blinded (surgeon), diagnostic clinical trial according to AMG and MPG. The fluorescent marker Bevacizumab-IRDye800CW has advantages over conventional methods of tumor imaging in terms of accuracy, patient safety and validity. In order to be able to detect this marker in vivo, special multispectral fluorescence-reflecting cameras (MFRI) were developed, which can be used for the intraoperative display of the tumor and potentially affected lymph nodes and which are now to be evaluated together with the fluorescence marker.
Detailed description
Complete surgical excision of the tumor (R0 resection) is the cornerstone of any curative therapy concept for cancer. In order to be able to achieve the highest possible rate of R0 resections, the tumor, its localization and spread needs to be more precisely represented. This should be possible through an intraoperative representation of the tumor by means of fluorescence imaging at the molecular level.
Vascular Endothelial Growth Factor (VEGF, or VEGF-A), which is expressed differently in normal and tumor tissue, is a suitable marker for molecular imaging, especially in gynecological cancer. Bevacizumab is a genetically engineered humanized monoclonal antibody that is directed against VEGF and is already therapeutically approved for the treatment of breast and ovarian cancer and has also shown efficacy in studies on endometrial cancer.
Fluorescence-labeled bevacizumab has advantages over conventional methods of tumor imaging in terms of accuracy, patient safety, cost efficiency and validity. A fluorescent marker, Bevacizumab-IRDye800CW, was developed and recently used in clinical trials in the Netherlands. In order to be able to detect this marker in vivo, special multispectral fluorescence-reflecting cameras (MFRI) were developed, which can be used for intraoperative visualization of the tumor and potentially affected lymph nodes. These systems can now be used to evaluate the fluorescent marker in clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: Bevacizumab-IRDye800CW |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- women of age ≥ 18 years able to give consent who have been informed in detail about the study beforehand and have given written consent to participate
- Patients with histologically confirmed unifocal VEGF-positive invasive breast cancer with an indication for BET
- Patients with histologically confirmed unilateral VEGF-positive DCIS with an indication for BET
- ECOG performance ≤ 2
- Pre-menopausal women had a negative pregnancy test prior to administration of the study medication
Key exclusion criteria (19 listed)
- Second malignancy in the breast and other organs
- Pregnant or breastfeeding patients
- Planned sentinel lymph node marking using patent blue
- Previous radiation therapy in the area to be examined
- Known or suspected hypersensitivity to the study medication (according to IMPD / SmPC) or other immunoglobulins
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-IRDye800CWAlso: Device: special multispectral fluorescence-reflecting camerasIn order to be able to detect this marker in vivo, special multispectral fluorescence-reflecting cameras (MFRI) were developed, which can be used for the intraoperative display of the tumor and potentially affected lymph nodes and which are now to be evaluated together with the fluorescence marker. | Drug | treatment arm |
Primary outcome
Determination of the sensitivity and specificity of bevacizumab- IRDye800CW
Time frame: 21 days
Determination of the sensitivity and specificity of bevacizumab- IRDye800CW with regard to the identification of the tumor margins compared with the histopathological findings (resection result R0, R1) as the gold standard
1 secondary outcome
Safety and Toxicity of Bevacizumab-IRDye800CW will be analyzed by absolute and relative frequencies of Safety events
Time frame: 21 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Individual participant dataSharing planned: Undecided. no patient specific data will be shared
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab-IRDye800CW in people with Breast Cancer, run by Technical University of Munich.
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 6 inclusion and 19 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: withdrawn, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Determination of the sensitivity and specificity of bevacizumab- IRDye800CW (time frame: 21 days). 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 4 May 2022.