Know Cancer

or
forgot password


N/A
18 Years
N/A
Open (Enrolling)
Both
Neuroendocrine Tumor

Thank you

Trial Information


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

Approximately 10 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

11-MIBG-005

NCT ID:

NCT01448083

Start Date:

October 2011

Completion Date:

Related Keywords:

  • Neuroendocrine Tumor
  • I-131 MIBG therapy
  • whole body I-123 MIBG scintigraphy
  • Neuroendocrine Tumors

Name

Location

Ochsner Medical Center - KennerKenner, Louisiana  70065