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

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ClinicalTrials.gov Identifier: NCT01931488
Recruitment Status : Unknown
Verified August 2013 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
First Posted : August 29, 2013
Last Update Posted : August 29, 2013
Sponsor:
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Neuroendocrine Tumors Other: MIBG label with I123 or I124 Device: SPECT imaging Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : August 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2016

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Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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 ClinicalTrials.gov identifier (NCT number): NCT01931488


Locations
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Israel
Tel-Aviv Sourasky Medical Center Recruiting
Tel-Aviv, Israel
Contact: ADVA RECHES       adva.reches@gmail.com   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Einat Even Sapir, PhD, MD Tel-Aviv Sourasky Medical Center

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Responsible Party: Michal Roll PhD,MBA, DIRECTOR, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01931488     History of Changes
Other Study ID Numbers: TASMC-12-ES-0341-CTIL
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: August 29, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
3-Iodobenzylguanidine
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals