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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Nuclear Medicine Consultants, Inc.
Sponsor:
Information provided by (Responsible Party):
Nuclear Medicine Consultants, Inc.
ClinicalTrials.gov Identifier:
NCT01448083
First received: October 3, 2011
Last updated: September 16, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Neuroendocrine Tumor
Other: Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis.

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Nuclear Medicine Consultants, Inc.:

Primary Outcome Measures:
  • 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. [ Time Frame: Approximately 10 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2011
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Neuroendocrine Tumor Clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448083

Contacts
Contact: Maria M Chester, RN (504) 464-8500 mchest@lsuhsc.edu

Locations
United States, Louisiana
Ochsner Medical Center - Kenner Recruiting
Kenner, Louisiana, United States, 70065
Principal Investigator: Richard J Campeau, MD         
Sponsors and Collaborators
Nuclear Medicine Consultants, Inc.
  More Information

No publications provided

Responsible Party: Nuclear Medicine Consultants, Inc.
ClinicalTrials.gov Identifier: NCT01448083     History of Changes
Other Study ID Numbers: 11-MIBG-005
Study First Received: October 3, 2011
Last Updated: September 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nuclear Medicine Consultants, Inc.:
I-131 MIBG therapy
whole body I-123 MIBG scintigraphy

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014