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68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Neuroendocrine Tumors


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Neuroendocrine Carcinoma

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Trial Information

68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Neuroendocrine Tumors


Inclusion Criteria:



- Known diagnosis of neuroendocrine tumor

- At least 18 years of age

- Able to provide informed consent

- Karnofsky score greater than 50

- Females of childbearing potential must have a negative pregnancy test at
screening/baseline

Exclusion Criteria:

- Serum creatinine >3.0 mg/dL (270 μM/L)

- Hepatic enzyme levels more than 5 times upper limit of normal.

- Known severe allergy or hypersensitivity to IV radiographic contrast.

- Use of any other investigational product or device within 30 days prior to
dosing, or known requirement for any other investigational agent prior to completion
of all scheduled study assessments.

- Patients with a body weight of 400 pounds or more or not able to enter the bore of
the PET/CT scanner due to BMI, because of the compromise in image quality with CT,
PET/CT and MRI that will result.

- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis,
etc.).

- Inability to complete the needed investigational and standard-of-care imaging
examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)

- Recognized concurrent active infection

- Any additional medical condition, serious intercurrent illness, or other extenuating
circumstance that, in the opinion of the Investigator, may significantly interfere
with study compliance.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

Determine if any adverse effects are associated with the scan and the number of patients that experience them.

Outcome Time Frame:

One year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

110588

NCT ID:

NCT01396382

Start Date:

August 2011

Completion Date:

August 2013

Related Keywords:

  • Neuroendocrine Carcinoma
  • neuroendocrine
  • neuroendocrine carcinoma
  • neuroendocrine tumor
  • carcinoid
  • carcinoid tumor
  • islet cell tumor
  • APUDoma
  • Gallium
  • PET Scan
  • Carcinoma
  • Carcinoma, Neuroendocrine
  • Neuroendocrine Tumors

Name

Location

Vanderbilt University Medical CenterNashville, Tennessee  37232-2516