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Radiolabeled Molecules for Medullary Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01915485
Recruitment Status : Unknown
Verified September 2016 by Instituto Nacional de Cancer, Brazil.
Recruitment status was:  Recruiting
First Posted : August 5, 2013
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):
Instituto Nacional de Cancer, Brazil

Brief Summary:
Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in its membrane. Furthermore, very little is available to treat patients who have disease progression. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate which is a ligand to somatostatin receptors.

Condition or disease Intervention/treatment Phase
Medullary Thyroid Cancer Radiation: Lu 177 Phase 4

Detailed Description:

Medullary thyroid carcinomas can also be located by scintigraphy with 111In-DTPA (diethylenetriamine pentaacetic acid) -octreotide. In some studies, there is a sensitivity for the detection of these tumors by this method, 50-70%. The relationship of calcitonin and carcinoembryonic antigen levels were significantly higher in patients in whom scintigraphy was performed with 111In-DTPA-octreotide. This implies that somatostatin receptors can be detected "in vivo" for different forms of medullary thyroid carcinoma Based on the specific binding of the analogs of somatostatin receptors present on the membrane of some tumors such as medullary thyroid been possible to devise a therapy to target-directed using both beta-emitting radionuclides (which have therapeutic properties) coupled to such molecules. The main radiopharmaceuticals used for this purpose are currently 177 Lu-DOTA-Tyr3-OCTREOTATE or 90Yttrium-DOTA]-TOC.

The medullary thyroid carcinoma (MTC) is a rare neuroendocrine tumor, accounting for only 4.9% of total thyroid carcinomas, however, compared to well differentiated carcinoma, presents a worse prognosis. The tumor staging, and restaging is essential since surgery is the only curative method. Elevated plasma concentrations of calcitonin (CT) and / or high levels of carcinoembryonic antigen (CEA), biochemical markers of MTC, suggest the presence of residual malignant disease / recurrence or metastasis at a distance. After surgery aggressive 40% of patients have persistent disease and about 10%, with undetectable post-surgery CT, develop tumor recurrence. At this point the therapeutic options are scarce and not available in our area. Although the investigators use the structural radiological study using ultrasound, computed tomography and magnetic resonance imaging for staging of the disease, they do not provide functional information. In this context, nuclear medicine examinations can add data such as growth potential and expression pattern of receptors for diagnostic and therapeutic purposes. In 2007, Ong SC. et al. Showed that 18 FDG PET / CT have the ability to detect residual disease, recurrent or metastatic disease with a sensitivity of 78% but only when calcitonin is up 1000pg/ml. Already Iten et al. Using the principle that these tumors express receptors for the somatostatin used OctreoScan ® and subsequent treatment with 90Yttrium-DOTA]-TOC showing not only an advantage for the location of the disease and the possibility of making an image guided therapy by. These authors also demonstrated a clinical benefit to the extent that 25% of the patients showed reduced calcitonin. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Lu177 in the Treatment of Progressive and Unresectable Metastatic Medullary Thyroid Cancer
Study Start Date : August 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Lu 177
progressive metastatic medullary thyroid cancer
Radiation: Lu 177
Patients will be submitted to 4 cycles of 177-Lu with 200mCi each

Primary Outcome Measures :
  1. Tumour Shrinkage [ Time Frame: 6-8 months ]
    RECIST 1.1 criteria

Secondary Outcome Measures :
  1. Quality of life improvement [ Time Frame: 6-8 months ]
    SF 36 pre and post therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Medullary Thyroid Cancer
  • Doubling time calcitonin and CEA less than 6 months
  • Measurable disease by cross- sectional imaging
  • Irresectable tumors masses
  • > 18 years of age

Exclusion Criteria:

  • < 18 years of age
  • Disease that can be treated with new surgical procedure
  • Stable disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01915485

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Contact: Fernanda Vaisman, MD, PhD (5521) 32071387

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Instituto Nacional do Cancer do Rio de Janeiro Recruiting
Rio de Janeiro, Brazil
Contact: Fernanda Vaisman   
Principal Investigator: Fernanda Vaisman, MD         
Sponsors and Collaborators
Instituto Nacional de Cancer, Brazil
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Principal Investigator: Fernanda Vaisman, MD, PhD National Cancer Institute, France
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Responsible Party: Instituto Nacional de Cancer, Brazil Identifier: NCT01915485    
Other Study ID Numbers: Lu177-med
First Posted: August 5, 2013    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue