Heart/Mediastinal Ratio Study for Potential Equivalence of Heart/Mediastinal Ratios at One and Two Hours to the Traditional Heart/Mediastinal Ratio Obtained at Four Hours

The purpose of this study is to determine if the measurement (with a standard nuclear camera) of radioactivity normally present in the nervous system of your heart at four hours after the injection of radioactive drug for your diagnostic I-123 MIBG scan is any different than radioactivity measured in your heart at one and/or two hours after your diagnostic scan injection. If equivalent information to the conventional 4 hr H/M ratio could be collected by obtaining H/M ratios at 1 or 2 hour windows, it would greatly facilitate patient acceptance of the procedure since the requirements for obtaining a valid H/M ratio would be considerably less time-consuming.

One hour before being injected with the drug (I-123 MIBG) for your MIBG scan, you will be given a standard dose of non-radioactive iodine (Lugol's solution) to block your thyroid from receiving the small amount of radiation that is a normal part of the MIBG scan. You will then be injected with MIBG, and you will have 10 minute pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours in addition to the standard 24 hour pictures. These pictures will be taken in the Nuclear Medicine Section, Department of Radiology at Ochsner Medical Center-Kenner. The experimental (research) part of this study is having the extra 10-minute pictures of your chest at 15 minutes, 1 hour, 2 hours, and 4 hours. Normally, pictures are only taken 24 hours after the injection. Therefore the research is limited to the four extra pictures taken, and involve no additional injections or I-123 drug beyond that you will be receiving regardless of whether you are part of this research.

Study Overview

• Status: Unknown
• Conditions: Neuroendocrine Tumor
• Intervention / Treatment: Other: Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Kenner, Louisiana, United States, 70065
      • Recruiting
      • Ochsner Medical Center - Kenner
      • Principal Investigator: Richard J Campeau, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Neuroendocrine Tumor Clinic

Description

Inclusion Criteria:

1. NET patients who are potential candidates for I-131 MIBG therapy, and are having whole body I-123 MIBG scintigraphy as standard of care.
2. Male or female patients ≥ 18 years of age.
3. Written informed consent from patients obtained in accordance to local guidelines.
4. History and physical exam indicating low likelihood, < 10 %, of any significant cardiac disease.
5. Echocardiogram within normal limits, including absence of valvular disease and normal LVEF.
6. Serum BNP within normal limits. -

Exclusion Criteria:

1. Patients on drugs which interfere with MIBG uptake - tricyclic antidepressants, phenylpropanolamine, pseudephredine, phenylephrine, sympathomimetics, amphetamines, reserpine, thorazine and thiothixines, calcium channel blockers, cocaine, and long-acting beta blockers.
2. >10% likelihood of any significant heart disease, including myocardial ischemia, cardiomyopathies, uncontrolled hypertension, congestive heart failure and valvular heart disease, e.g. see "Likelihood of Assessment of Coronary Artery Disease" below.
3. History of uncontrolled diabetes mellitus
4. Signs/symptoms of neurological diseases (e.g., Parkinsonian syndromes) or other disease known to affect the sympathetic nervous system.
5. Female patients who are pregnant or nursing (lactating), or adults of reproductive potential who are not using effective birth control methods. If there is any question of pregnancy, a serum bHCg will be collected.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Neuroendocrine tumor patients	Other: Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis.; Each subject will receive a 370 MBq (10 mCi ) (±10%) injection of I- 123 MIBG. Myocardial I-123 MIBG uptake will be quantitatively measured over time via planar imaging acquired at 15 minutes, one, two, four, and at 24 hours (the standard of care time point for NET patient imaging) post I-123MIBG injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The heart/mediastinal ratio (H/M) at one or two hours post injection of AdreView™ (I-123 MIBG) in neuroendocrine tumor patients is equivalent to the standard 4 hr calculation.	Approximately 10 months

Collaborators and Investigators

• Sponsor: Nuclear Medicine Consultants, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2011

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): September 18, 2012
• Last Update Submitted That Met QC Criteria: September 16, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: I-131 MIBG therapy; whole body I-123 MIBG scintigraphy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors
• Other Study ID Numbers: 11-MIBG-005