Papillary Thyroid CancerPhase 1TARGETNCT03470259
Precision Thyroid Cancer Surgery With Molecular Fluorescent Guided Imaging
A Phase 1 study testing IV adminstration of EMI-137, Multispectral Fluorescence Reflectance Imaging and Spectroscopy in people with Papillary Thyroid Cancer and Lymph Node Metastases, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial summary
Almost 50 % of papillary thyroid cancer (PTC) patients have central lymph node metastases (CLNM), which are associated with a high risk of persistent or recurrent disease. However, the practice of performing a prophylactic central lymph node dissection (PCLND) routinely remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Papillary Thyroid Cancer, Lymph Node Metastases
- What is being tested?
- IV adminstration of EMI-137, Multispectral Fluorescence Reflectance Imaging and Spectroscopy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesNetherlands
- Study dates
- 20 Jun 2018to 31 Dec 2019
- 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 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.
Show all 9Show fewer
- 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
2 sites in 1 country.
Netherlands2 sites
University Medical Center Groningen
Groningen, 9713GZ
Erasmus Medical Center
Rotterdam
About this study
Official title: Detection of Thyroid Cancer and Central Lymph Node Metastases Using EMI-137 Enhanced Molecular Fluorescent Guided Imaging: a Multicentre Feasibility and
Almost 50 % of papillary thyroid cancer (PTC) patients have central lymph node metastases (CLNM), which are associated with a high risk of persistent or recurrent disease. However, the practice of performing a prophylactic central lymph node dissection (PCLND) routinely remains controversial. The proponents argue that without a PCLND, PTC patients with positive lymph nodes have an increased risk of local recurrence, and postponed node dissection leads to with 5-6 fold higher risk of morbidity. If performed, PCLND in clinical node negative patients increases staging to pN1 in more than 50% of the cases without increasing survival. The complication rate in PCLND is lower when compared to a technically challenging re-exploration in recurrent disease, with reported incidences of 0.6% and 7.3-20%, respectively. Opponents of routine PCLND point out the lack of randomized clinical trials and object to treatment-induced hypo-parathyroidism and recurrent nerve damage for the N0 patients. Currently, no diagnostic tool is available which reliably identifies these patient categories. Therefore, there is a clear need for novel diagnostic imaging modalities that overcome this issue. Molecular Fluorescence Guided Surgery (MFGS) is potentially such a diagnostic tool. The administration of NIR fluorescent tracers can increase detection accuracy of cancer and nodal metastatic tissue using macroscopic MFGS. Therefore, we aimed to identify a GMP-produced near infrared (NIR) tracer that potentially has a high target-to-background ratio in PTC compared to normal thyroid tissue. Tyrosine-protein kinase Met (c-Met) is significantly upregulated at the protein level in PTC compared to normal thyroid tissue. The investigators therefore hypothesize that the GMP-produced NIR-fluorescent tracer EMI-137 (targeting c-Met, peak emission at 675 nm range) might be useful for intraoperative imaging of PTC and nodal metastases. The investigators' aim is to investigate if the administration of EMI-137 is a feasible approach to detect PTC nodal metastases. Ultimately, this method might be useful to improve patient selection for CLND. Eventually, we might also be able to visualize multifocality, more selective lateral neck dissections and asses residual tissue after thyroidectomy. Ultimately, all of these strategies may reduce overtreatment, morbidity, and costs while maintaining the same or better effectiveness with a lower recurrence rate and improved quality of life.
Read the detailed description
See brief summary
- Conditions
- Papillary Thyroid Cancer, Lymph Node Metastases
- Being tested
- IV adminstration of EMI-137, Multispectral Fluorescence Reflectance Imaging, Spectroscopy
- Medical subject headings
- Thyroid Cancer, Papillary, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV adminstration of EMI-137Drug
Also called IMP administration
Intravenous administration of the fluorescent tracer EMI-137 approximately two hours before incision. Thereafter will be an observational period of an hour.
Multispectral Fluorescence Reflectance ImagingDevice
Also called MFRI
A multispectral Near Infrared Fluorescence (NIRF) camera system sensitive for EMI-137 fluorescence will be used for only ex-vivo Multispectral Fluorescence Reflectance Imaging (MFRI) of the thyroid gland and/or lymph node compartment.
SpectroscopyDevice
A spectroscopy system sensitive for EMI-137 fluorescence will be used for only ex-vivo spectroscopy of the thyroid gland and/or lymph node compartment.
| Study group | Role | What they receive |
|---|---|---|
| EMI-137 0.09mg/kg administration | Experimental | Three patients will be once administered with EMI-137 0.09 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system.
After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. Receives: Drug: IV adminstration of EMI-137; Device: Multispectral Fluorescence Reflectance Imaging; Device: Spectroscopy |
| EMI-137 0.13mg/kg administration | Experimental | Three patients will be once administered with EMI-137 0.13 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system.
After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. Receives: Drug: IV adminstration of EMI-137; Device: Multispectral Fluorescence Reflectance Imaging; Device: Spectroscopy |
| EMI-137 0.18mg/kg administration | Experimental | Three patients will be once administered with EMI-137 0.18 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system.
After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. Receives: Drug: IV adminstration of EMI-137; Device: Multispectral Fluorescence Reflectance Imaging; Device: Spectroscopy |
| EMI-137 0.045mg/kg administration | Experimental | If we have a excellent tumor to background ratio ((tumor fluorescence)/(surrounding tissue fluorescence)) in the 0.09 mg/kg group, we will de-escalate back to a 0.045 mg/kg group to evaluate TBR and reduce possible tracer toxicity in a thyroid cancer population with 90% 20 year survival.
Three patients will be once administered with EMI-137 0.045 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system.
After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. Receives: Drug: IV adminstration of EMI-137; Device: Multispectral Fluorescence Reflectance Imaging; Device: Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of Molecular Fluorescence Guided Surgery using EMI-137
To determine the optimal dose of the c-Met targeting NIRF tracer EMI-137 for an adequate TBR in PTC lymph nodes metastases using 3, and possibly 4, different dosages op EMI-137.
Measured: From tracer administration until after data analyses which will take up to 1.5year
Secondary outcomes (7)
Safety of using EMI-137 through monitoring vital signs
To evaluate the safety of EMI-137 through monitoring vital signs for evaluating possible (severe) adverse events.
Measured: 1 day
Safety of using EMI-137 through monitoring injection site
To evaluate the safety of EMI-137 through monitoring the injection site for evaluating possible (severe) adverse events.
Measured: 1 day
Feasibility of MFGS for detecting nodal metastasis
To evaluate the feasibility of MFGS for the assessment of PTC and nodal metastasis by calculating target-to-background ratio.
Measured: Up to one year
Feasibility of spectroscopy for detecting fluorescence of PTC and lymph nodes
To determine the feasibility of ex vivo spectroscopy measurements of PTC and lymph nodes for quantification of the fluorescence signal of EMI-137
Measured: Up to one year
Validation of flourescence
To correlate and validate fluorescence signals detected ex vivo with histopathology and immunohistochemistry by determining if high flourescence areas show tumorcells in pathological examination.
Measured: Up to one year
Distribution of EMI-137
To evaluate the distribution of EMI-137 on a microscopic level using fluorescence microscopy.
Measured: Up to 1.5 year
Sensitivity and specificity of EMI-137
To quantify sensitivity and specificity of EMI-137 for PTC and nodal metastasis in order to make a power size calculation for a possible subsequent diagnostic accuracy study.
Measured: Up to 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start20 Jun 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Papillary Thyroid CancerStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Schelto Kruijfff, MD, PhD, Principal investigator, University Medical Center GroningenGooitzen M van Dam, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470259
- Sponsor's protocol ID
- NL62817.042.17
- Acronym
- TARGET
- Status last verified
- Apr 2024
- First submitted
- 21 Feb 2018
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Metman MJH, Jonker PKC, Sondorp LHJ, van Hemel BM, Sywak MS, Gill AJ, Jansen L, van Diest PJ, van Ginhoven TM, Lowik CWGM, Nguyen AH, Robinson DJ, van Dam GM, Links TP, Coppes RP, Fehrmann RSN, Kruijff S. MET-receptor targeted fluorescent imaging and spectroscopy to detect multifocal papillary thyroid cancer. Eur J Nucl Med Mol Imaging. 2024 Jul;51(8):2384-2394. doi: 10.1007/s00259-023-06525-5. Epub 2023 Nov 29.
PubMed 38017325Jonker PKC, Metman MJH, Sondorp LHJ, Sywak MS, Gill AJ, Jansen L, Links TP, van Diest PJ, van Ginhoven TM, Lowik CWGM, Nguyen AH, Coppes RP, Robinson DJ, van Dam GM, van Hemel BM, Fehrmann RSN, Kruijff S. Intraoperative MET-receptor targeted fluorescent imaging and spectroscopy for lymph node detection in papillary thyroid cancer: novel diagnostic tools for more selective central lymph node compartment dissection. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3557-3570. doi: 10.1007/s00259-022-05763-3. Epub 2022 Apr 7.
PubMed 35389070
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Thyroid Cancer and Central Lymph Node Metastases Using EMI-137 Enhanced Molecular Fluorescent Guided Imaging: a Multicentre Feasibility and
- ClinicalTrials.gov ID
- NCT03470259
- Acronym / sponsor ID
- TARGET / NL62817.042.17
- Conditions
- Papillary Thyroid Cancer, Lymph Node Metastases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Mar 2018 (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.
Almost 50 % of papillary thyroid cancer (PTC) patients have central lymph node metastases (CLNM), which are associated with a high risk of persistent or recurrent disease. However, the practice of performing a prophylactic central lymph node dissection (PCLND) routinely remains controversial. The proponents argue that without a PCLND, PTC patients with positive lymph nodes have an increased risk of local recurrence, and postponed node dissection leads to with 5-6 fold higher risk of morbidity. If performed, PCLND in clinical node negative patients increases staging to pN1 in more than 50% of the cases without increasing survival. The complication rate in PCLND is lower when compared to a technically challenging re-exploration in recurrent disease, with reported incidences of 0.6% and 7.3-20%, respectively. Opponents of routine PCLND point out the lack of randomized clinical trials and object to treatment-induced hypo-parathyroidism and recurrent nerve damage for the N0 patients. Currently, no diagnostic tool is available which reliably identifies these patient categories. Therefore, there is a clear need for novel diagnostic imaging modalities that overcome this issue. Molecular Fluorescence Guided Surgery (MFGS) is potentially such a diagnostic tool. The administration of NIR fluorescent tracers can increase detection accuracy of cancer and nodal metastatic tissue using macroscopic MFGS. Therefore, we aimed to identify a GMP-produced near infrared (NIR) tracer that potentially has a high target-to-background ratio in PTC compared to normal thyroid tissue. Tyrosine-protein kinase Met (c-Met) is significantly upregulated at the protein level in PTC compared to normal thyroid tissue. The investigators therefore hypothesize that the GMP-produced NIR-fluorescent tracer EMI-137 (targeting c-Met, peak emission at 675 nm range) might be useful for intraoperative imaging of PTC and nodal metastases. The investigators' aim is to investigate if the administration of EMI-137 is a feasible approach to detect PTC nodal metastases. Ultimately, this method might be useful to improve patient selection for CLND. Eventually, we might also be able to visualize multifocality, more selective lateral neck dissections and asses residual tissue after thyroidectomy. Ultimately, all of these strategies may reduce overtreatment, morbidity, and costs while maintaining the same or better effectiveness with a lower recurrence rate and improved quality of life.
Detailed description
See brief summary
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| EMI-137 0.09mg/kg administration | Experimental | Drug: IV adminstration of EMI-137, Device: Multispectral Fluorescence Reflectance Imaging, Device: SpectroscopyThree patients will be once administered with EMI-137 0.09 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system. After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. |
| EMI-137 0.13mg/kg administration | Experimental | Drug: IV adminstration of EMI-137, Device: Multispectral Fluorescence Reflectance Imaging, Device: SpectroscopyThree patients will be once administered with EMI-137 0.13 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system. After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. |
| EMI-137 0.18mg/kg administration | Experimental | Drug: IV adminstration of EMI-137, Device: Multispectral Fluorescence Reflectance Imaging, Device: SpectroscopyThree patients will be once administered with EMI-137 0.18 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system. After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. |
| EMI-137 0.045mg/kg administration | Experimental | Drug: IV adminstration of EMI-137, Device: Multispectral Fluorescence Reflectance Imaging, Device: SpectroscopyIf we have a excellent tumor to background ratio ((tumor fluorescence)/(surrounding tissue fluorescence)) in the 0.09 mg/kg group, we will de-escalate back to a 0.045 mg/kg group to evaluate TBR and reduce possible tracer toxicity in a thyroid cancer population with 90% 20 year survival. Three patients will be once administered with EMI-137 0.045 mg/kg. Thereafter the patient will be observed for an hour. Two hours after injection surgery will be performed and only ex-vivo imaging and spectroscopy will be performed of thyroid glands and lymph nodes with a multispectral Near Infrared Fluorescence (NIRF) camera system and spectroscopy system. After interim analysis will be decided if this dosage group has an adequate tumor-to-background ratio and dose extension will be performed. |
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 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 |
|---|---|---|
| IV adminstration of EMI-137Also: IMP administrationIntravenous administration of the fluorescent tracer EMI-137 approximately two hours before incision. Thereafter will be an observational period of an hour. | Drug | EMI-137 0.045mg/kg administration, EMI-137 0.09mg/kg administration, EMI-137 0.13mg/kg administration, EMI-137 0.18mg/kg administration |
| Multispectral Fluorescence Reflectance ImagingAlso: MFRIA multispectral Near Infrared Fluorescence (NIRF) camera system sensitive for EMI-137 fluorescence will be used for only ex-vivo Multispectral Fluorescence Reflectance Imaging (MFRI) of the thyroid gland and/or lymph node compartment. | Device | EMI-137 0.045mg/kg administration, EMI-137 0.09mg/kg administration, EMI-137 0.13mg/kg administration, EMI-137 0.18mg/kg administration |
| SpectroscopyA spectroscopy system sensitive for EMI-137 fluorescence will be used for only ex-vivo spectroscopy of the thyroid gland and/or lymph node compartment. | Device | EMI-137 0.045mg/kg administration, EMI-137 0.09mg/kg administration, EMI-137 0.13mg/kg administration, EMI-137 0.18mg/kg administration |
Primary outcome
The feasibility of Molecular Fluorescence Guided Surgery using EMI-137
Time frame: From tracer administration until after data analyses which will take up to 1.5year
To determine the optimal dose of the c-Met targeting NIRF tracer EMI-137 for an adequate TBR in PTC lymph nodes metastases using 3, and possibly 4, different dosages op EMI-137.
7 secondary outcomes
Safety of using EMI-137 through monitoring vital signs
Time frame: 1 day
Safety of using EMI-137 through monitoring injection site
Time frame: 1 day
Feasibility of MFGS for detecting nodal metastasis
Time frame: Up to one year
Feasibility of spectroscopy for detecting fluorescence of PTC and lymph nodes
Time frame: Up to one year
Validation of flourescence
Time frame: Up to one year
Distribution of EMI-137
Time frame: Up to 1.5 year
Sensitivity and specificity of EMI-137
Time frame: Up to 1.5 year
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 16 Apr 2024.
- Derived from this study: PubMed 38017325Metman MJH, Jonker PKC, Sondorp LHJ, van Hemel BM, Sywak MS, Gill AJ, Jansen L, van Diest PJ, van Ginhoven TM, Lowik CWGM, Nguyen AH, Robinson DJ, van Dam GM, Links TP, Coppes RP, Fehrmann RSN, Kruijff S. MET-receptor targeted fluorescent imaging and spectroscopy to detect multifocal papillary thyroid cancer. Eur J Nucl Med Mol Imaging. 2024 Jul;51(8):2384-2394. doi: 10.1007/s00259-023-06525-5. Epub 2023 Nov 29.
- Derived from this study: PubMed 35389070Jonker PKC, Metman MJH, Sondorp LHJ, Sywak MS, Gill AJ, Jansen L, Links TP, van Diest PJ, van Ginhoven TM, Lowik CWGM, Nguyen AH, Coppes RP, Robinson DJ, van Dam GM, van Hemel BM, Fehrmann RSN, Kruijff S. Intraoperative MET-receptor targeted fluorescent imaging and spectroscopy for lymph node detection in papillary thyroid cancer: novel diagnostic tools for more selective central lymph node compartment dissection. Eur J Nucl Med Mol Imaging. 2022 Aug;49(10):3557-3570. doi: 10.1007/s00259-022-05763-3. Epub 2022 Apr 7.
- 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.
Schelto Kruijfff, MD, PhD principal investigator
University Medical Center Groningen
Gooitzen M van Dam, MD, PhD principal investigator
University Medical Center Groningen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV adminstration of EMI-137, Multispectral Fluorescence Reflectance Imaging and Spectroscopy in people with Papillary Thyroid Cancer and Lymph Node Metastases, run by University Medical Center Groningen at 2 sites 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 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The feasibility of Molecular Fluorescence Guided Surgery using EMI-137 (time frame: From tracer administration until after data analyses which will take up to 1.5year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03470259, which also lists 2 linked publications.
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 16 Apr 2024.