Radiolabeled Molecules for Medullary Thyroid Cancer

September 2, 2016 updated by: Instituto Nacional de Cancer, Brazil

The Use of Lu177 in the Treatment of Progressive and Unresectable Metastatic Medullary Thyroid Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil
        • Recruiting
        • Instituto Nacional do Cancer do Rio de Janeiro
        • Contact:
        • Principal Investigator:
          • Fernanda Vaisman, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumour Shrinkage
Time Frame: 6-8 months
RECIST 1.1 criteria
6-8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life improvement
Time Frame: 6-8 months
SF 36 pre and post therapy
6-8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancer, Brazil

Investigators

  • Principal Investigator: Fernanda Vaisman, MD, PhD, National Cancer Institute, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lu177-med

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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