Papillary thyroid carcinoma
Conditions
Interventions
Tracer administration: EMI-137 will be administered 2 hours prior to incision
by infusion and patients will be monitored for potential side effects. Dosages
administered throughout the study will be
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age * 18 years, eligible for surgery 2. Bethesda VI fine needle aspiration (FNA) thyroid or FNA proven PTC metastasis (primary or recurrence). 3. Scheduled to undergo central and/or lateral lymph node dissection with or without thyroidectomy as discussed in the Multi-Disciplinary Thyroid Board. 4. WHO performance score of 0-2. 5. Written informed consent. 6. Mentally competent person who is able and willing to comply with study procedures. 7. 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.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breast feeding 2. Advanced stage thyroid cancer not suitable for surgical resection 3. Medical or psychiatric conditions that compromise the patient*s ability to give informed consent 4. Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment 5. The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months 6. 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 7. Any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Fluorescent signal levels defined as Tumor-to-Background Ratio (TBR) derived from PTC nodal metastasis and normal tissue. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Number of (severe) adverse events (SAE/AEs). - Correlation of the ex-vivo fluorescent signal in PTC, nodal metastasis and normal tissue with other biological and molecular parameters (IHC). - Macroscopic and real-time quantification of the fluorescent signal of pathological confirmed PTC, nodal metastasis and normal tissue observed by means of the MDSFR/SFF spectroscopy probe (M/m3). - Distribution of EMI-137 in PTC, lymph nodes and normal tissue as identified by SDS-PAGE and/or ELISA and/or fluorescence microscopy. - Comparison between the amount of nodal metastasis found with preoperative imaging and the amount of nodal metastasis identified based on fluorescence signals. | — |
Countries
Netherlands
Outcome results
None listed