Precision Thyroid Cancer Surgery With Molecular Fluorescent Guided Imaging
Ключові слова
Анотація
Опис
See brief summary
Дати
Востаннє перевірено: | 12/31/2019 |
Перший поданий: | 02/20/2018 |
Орієнтовна реєстрація подана: | 03/11/2018 |
Опубліковано вперше: | 03/18/2018 |
Останнє оновлення надіслано: | 01/15/2020 |
Останнє оновлення опубліковано: | 01/17/2020 |
Фактична дата початку навчання: | 06/19/2018 |
Розрахункова дата первинного завершення: | 12/30/2019 |
Розрахункова дата завершення дослідження: | 12/30/2019 |
Стан або захворювання
Втручання / лікування
Drug: IV adminstration of EMI-137
Device: Multispectral Fluorescence Reflectance Imaging
Device: Spectroscopy
Фаза
Групи рук
Рука | Втручання / лікування |
---|---|
Experimental: EMI-137 0.09mg/kg administration 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. | |
Experimental: EMI-137 0.13mg/kg administration 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. | |
Experimental: EMI-137 0.18mg/kg administration 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. | |
Experimental: EMI-137 0.045mg/kg administration 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. |
Критерії прийнятності
Вік, придатний для навчання | 18 Years До 18 Years |
Стать, яка підходить для вивчення | All |
Приймає здорових добровольців | Так |
Критерії | 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: 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. |
Результат
Заходи первинного результату
1. The feasibility of Molecular Fluorescence Guided Surgery using EMI-137 [From tracer administration until after data analyses which will take up to 1.5year]
Заходи вторинного результату
1. Safety of using EMI-137 through monitoring vital signs [1 day]
2. Safety of using EMI-137 through monitoring injection site [1 day]
3. Feasibility of MFGS for detecting nodal metastasis [Up to one year]
4. Feasibility of spectroscopy for detecting fluorescence of PTC and lymph nodes [Up to one year]
5. Validation of flourescence [Up to one year]
6. Distribution of EMI-137 [Up to 1.5 year]
7. Sensitivity and specificity of EMI-137 [Up to 1.5 year]