NCT02038738

Brief Summary

Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET Scan is a novel scanning method that may have improved sensitivity and resolution specifically for neuroendocrine tumors. Patients with neuroendocrine tumors will be imaged with this agent and it will be compared to conventional imaging methods to determine the safety and efficacy of this radiopharmaceutical.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

5 years

First QC Date

January 14, 2014

Last Update Submit

January 16, 2014

Conditions

NeuroendocrineNeuroendocrine TumorNeuroendocrine CancerNeuroendocrine CarcinomaCarcinoidCarcinoid TumorIslet Cell TumorApudoma

Keywords

galliumGaPET Scan

Outcome Measures

Primary Outcomes (1)

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

    5 years

Secondary Outcomes (2)

  • Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques

    5 years

  • We want to determine if the 68Ga-DOTATATE PET Scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT)

    5 years

Study Arms (1)

Scan

EXPERIMENTAL

We will perform 68Ga-DOTATATE PET scans on subjects.

Drug: 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.

Interventions

68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.DRUG
Scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Known diagnosis of neuroendocrine tumor or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen where clinically indicated
  • At least 18 years of age
  • Able to provide informed consent
  • Karnofsky performance score greater than 50
  • Females of childbearing potential must have a negative pregnancy test at screening/baseline

You may not qualify if:

  • Serum creatinine \> 2.0 mg/dL
  • Hepatic enzyme levels more than 3 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 standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
  • Recognized concurrent active infection
  • Previous systemic or radiation treatment for another cancer of any type within the last 2 years
  • Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Medical Center - Kenner

Kenner, Louisiana, 70065, United States

Location

MeSH Terms

Conditions

Neuroendocrine TumorsCarcinoma, NeuroendocrineCarcinoid TumorAdenoma, Islet CellApudoma

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialAdenomaPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Richard J. Campeau, M.D.

CONTACT

504-464-8500

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology and Internal Medicine

Study Record Dates

First Submitted

January 14, 2014

First Posted

January 17, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2019

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

US(1)