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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Nuclear Medicine Consultants, Inc..
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448083
First Posted: October 7, 2011
Last Update Posted: September 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nuclear Medicine Consultants, Inc.
  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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Nuclear Medicine Consultants, Inc.
ClinicalTrials.gov Identifier: NCT01448083     History of Changes
Other Study ID Numbers: 11-MIBG-005
First Submitted: October 3, 2011
First Posted: October 7, 2011
Last Update Posted: September 18, 2012
Last Verified: September 2012

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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial