68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

NCT01396382 | Completed Phase 2 Results DMC

• 2 other identifiers: VICC GI 1136110588
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.

Conditions

Neuroendocrine Carcinoma

Keywords

neuroendocrine; neuroendocrine carcinoma; neuroendocrine tumor; carcinoid; carcinoid tumor; islet cell tumor; APUDoma; Gallium; PET Scan

Outcome Measures

Primary Outcomes (1)

• Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan

  Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).

  at 1 year

Secondary Outcomes (1)

• Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability

  at 1 year

Study Arms (1)

68Ga-DOTATATE PET

EXPERIMENTAL

Patients will receive a 68Ga-DOTATATE PET scans

Radiation: 68Ga-DOTATATE PET scan

Interventions

68Ga-DOTATATE PET scan RADIATION

68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography (PET). Efficacy of the 68Ga-DOTATATE PET scan was assessed and compared to 111In-Pentetreotide scan and to scans with CT and/or MRI. Safety and toxicity were also assessed with pre-injection and post-imaging vital signs, pulse oximetry on room air, 12 lead ECGs, and blood laboratory tests, including tumor markers, liver and renal functions and blood counts, and direct patient questioning. Late delayed tumor markers, liver and renal functions and blood counts were assessed when available.

68Ga-DOTATATE PET

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• Walker RC, Smith GT, Liu E, Moore B, Clanton J, Stabin M. Measured human dosimetry of 68Ga-DOTATATE. J Nucl Med. 2013 Jun;54(6):855-60. doi: 10.2967/jnumed.112.114165. Epub 2013 Mar 20.

  PMID: 23516312 RESULT

• Deppen SA, Liu E, Blume JD, Clanton J, Shi C, Jones-Jackson LB, Lakhani V, Baum RP, Berlin J, Smith GT, Graham M, Sandler MP, Delbeke D, Walker RC. Safety and Efficacy of 68Ga-DOTATATE PET/CT for Diagnosis, Staging, and Treatment Management of Neuroendocrine Tumors. J Nucl Med. 2016 May;57(5):708-14. doi: 10.2967/jnumed.115.163865. Epub 2016 Jan 14.

  PMID: 26769865 RESULT

MeSH Terms

Conditions

Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Carcinoid Tumor; Adenoma, Islet Cell; Apudoma

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Adenoma; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Limitations and Caveats

Long term follow-up of lab values was limited in some patients who lived outside the local region.

Results Point of Contact

• Title: Dr. Ronald Walker
• Organization: Vanderbilt-Ingram Cancer Center

ronald.walker@vanderbilt.edu

615-343-8516

Study Officials

• Ronald C. Walker, MD

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Radiology

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 18, 2011
• Study Start: March 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 29, 2016
• Results First Posted: March 29, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)