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

Primary Purpose

Parkinson Disease, Neuroendocrine Tumors

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
MIBG label with I123 or I124
SPECT imaging
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tel-Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

MIBG label with I123 or I124

Arm Description

evaluate the added value of PET-CT with 124I-MIBG tracer, compared to planar and SPECT imaging with the routine 123I-MIBG tracers/

Outcomes

Primary Outcome Measures

Uptake of 123I-MIBG
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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2013
Last Updated
August 28, 2013
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01931488
Brief Title
124I-MIBG Tracer Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors.
Official Title
The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors. Comparison With 123I-MIBG.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine tumors. Comparison with 123I-MIBG.
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 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. Staging and follow-up of pts. with neuroendocrine malignancies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Neuroendocrine Tumors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIBG label with I123 or I124
Arm Type
Other
Arm Description
evaluate the added value of PET-CT with 124I-MIBG tracer, compared to planar and SPECT imaging with the routine 123I-MIBG tracers/
Intervention Type
Other
Intervention Name(s)
MIBG label with I123 or I124
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SPECT imaging
Primary Outcome Measure Information:
Title
Uptake of 123I-MIBG
Description
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.
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einat Even Sapir, PhD, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel-Aviv
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ADVA RECHES
Email
adva.reches@gmail.com

12. IPD Sharing Statement

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

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