124I-MIBG Tracer Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors.

August 28, 2013 updated by: Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center

The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors. Comparison With 123I-MIBG.

The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine tumors. Comparison with 123I-MIBG.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The autonomic nervous system consists of sympathetic and parasympathetic innervation.

The neurotransmitter of the sympathetic system is norepinephrine (NE) which in response to a stimulus, is released to the synaptic space Guanethidine is a false neurotransmitter analog of NE that is not catabolized . When labeled with radioactive iodine the radiotracer meta-iodobenzylguanidine (as I-MIBG) may be used for localization of different clinical and pathological conditions. There are two main indications for scintigrpahy with labeled MIBG 1. Whole body imaging of neuroendocrine tumors such as phechromocytoma and neuroblastoma. Scintigraphy allows staging of the disease as well as follow up in patients with MIBG-avid tumors. Moreover, when labeled with high doses of 131I it can be used for treatment in patients with metastatic neuroendocrine tumors. 2. the other indication of labeled MIBG scintigraphy is for assessment of myocardial sympathetic nerve endings Autonomic disturbances are of the common symptoms in Parkinson disease (PD). They may appear early in the disease occasionally prior to the motor symptoms, thus raising a potential use of autonomic system assessment as a biological marker for prediction of future development of motor PD.

Labeled MIBG imaging is a potential test for determining of the integrity of the individual autonomic function. Reduced MIBG uptake indicates postganglionic sympathetic dysfunction, which has been observed during the early stages of PD. MIBG scintigraphy is thought to be a sensitive modality for the diagnosis of PD, assisting in the differential diagnosis of other parkinsonian diseases, PD and other movement disorders. This method has also been reported to be of a high specificity.

The labeled MIBG used routinely is the tracer labeled with 123I which can be used with gamma camera for performance of planar imaging or 3D SPECT images. 123I emits predominantly γ photons with energies of 159 keV and has a half-life of 13.2 hour.

Quantitation of 123I MIBG myocardial uptake by the Heart to-Mediastinum ratio (H/M) measured from planar imaging has been found to be of predictive value for assessment of prognosis for cardiac events. H/M obtained from 123I MIBG SPECT was reported to improve the differentiation between subjects with normal and those with abnormal MIBG uptake.

Unlike 123I which is a gamma emitting isotope 124I, a positron emitter, with a half-life of 4.2 d, can be used for positron emission tomography (PET) thus allowing a better as well as quantification of tracer accumulation Studies using 124I-MIBG positron emission tomography was initiated as early as 1992. Preliminary studies demonstrated that imaging with 124I-MIBG in humans is safe when using the correct amount of radioactivity tracer.

In this study we propose to perform two images sessions. First would be the injection of 6mCi 123I-MIBG which results in radiation dose of 4.2 mSv.In the second session 0.8 mCi 124I-MIBG will be injected which results in radiation dose of 7.4 mSv. The estimated total radiation dose to the patient of both studies is 11.8 mSv. When comparing to the radiation doses of daily routine scintigraphy: The radiation dose of bone scan (25 mCi Tc MDP) is 5.3 mSv. The radiation dose of 12 mCi 18F-FDG PET-CT is 13.32 mSv.

Trail Objectives Given the merits of MIBG ligand and the 124I positron emission tomography, the purpose of this study is to evaluate the added value of PET-CT with 124I-MIBG tracer, compared to planar and SPECT imaging with the routine 123I-MIBG tracers for

  1. Assessment of the Myocardial Sympathetic Denervation of patients with Parkinson and family members of patienst with PD who are carriers of the mulation for PD.
  2. Staging and follow-up of pts. with neuroendocrine malignancies.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

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:

  • Age ≥ 18
  • Signed Informed Consent
  • Patients diagnosed with Parkinson disease
  • Patients with histologically confirmed neuroendocrine tumors

Exclusion Criteria:

  • Age < 18
  • Any cardiovascular disease
  • Taking medications that influence the sympathetic system

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MIBG label with I123 or I124
evaluate the added value of PET-CT with 124I-MIBG tracer, compared to planar and SPECT imaging with the routine 123I-MIBG tracers/
Other: MIBG label with I123 or I124
PD Patients who are not allergic to Iodine will be given 8 drops of Lugol . 30 min later, patients will be injected with 123I-MIBG 6 mci (222 MBq). 3 hours post-injection patients will undergo planar and SPECT imaging. at another day, patients will be injected with 124I-MIBG 0.8 mci (29.6 MBq). 3 hours post-injection patients will undergo PET-CT imaging.whole-body imaging. in the evaluation of neuroendocrine tumors-Patients who are not allergic to Iodine will be given 8 drops of Lugol.30 min later, patients will be injected with 123I-MIBG 6 mCi (222 MBq).3 hours and 24 hours post-injection patients will undergo planar and SPECT imaging. at another day, patients will be injected with 124I-MIBG 0.8 mCi (29.6 MBq). 3 hours and 24 hours post-injection patients will undergo PET-CT imaging.
Device: SPECT imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of 123I-MIBG
Time Frame: day 1
At day 1 patients will be injected with 123I-MIBG 6 mci (222 MBq). 3 hours post-injection patients will undergo planar and SPECT imaging. Uptake of 123I-MIBG will be quantified as heart/mediastinum ratio measured from planar imaging.
day 1

Collaborators and Investigators

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

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Einat Even Sapir, PhD, MD, Tel-Aviv Sourasky Medical Center

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)

January 1, 2015

Study Completion (Anticipated)

January 1, 2016

Study Registration Dates

First Submitted

August 14, 2013

First Submitted That Met QC Criteria

August 28, 2013

First Posted (Estimate)

August 29, 2013

Study Record Updates

Last Update Posted (Estimate)

August 29, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-12-ES-0341-CTIL

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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