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

NCT01931488 | Unknown Phase 2

• 1 other identifier: TASMC-12-ES-0341-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease; Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

• 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.

  day 1

Study Arms (1)

MIBG label with I123 or I124

OTHER

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; Device: SPECT imaging

Interventions

MIBG label with I123 or I124 OTHER

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.

MIBG label with I123 or I124

SPECT imaging DEVICE

MIBG label with I123 or I124

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, Israel

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Neuroendocrine Tumors

Interventions

Iodine-123; Iodine-124; Tomography, Emission-Computed, Single-Photon

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Einat Even Sapir, PhD, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIRECTOR

Study Record Dates

• First Submitted: August 14, 2013
• First Posted: August 29, 2013
• Study Start: August 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2016
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

IL (1)