Impact of 68Ga-DOTATATE PET/CT on the Management of Neuroendocrine Tumors: The Referring Physician's Perspective

NCT01873248 | Completed Early Phase 1 FDA Drug

• 3 other identifiers: 12-00192068Ga-DOTATATE PET/CTNCI-2016-01796
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Somatostatin receptor imaging with 68Ga-DOTATATE PET/CT (DOTATATE) is increasingly used for managing patients with neuroendocrine tumors. The objective of this study was to determine referring physicians' perspectives on the impact of DOTATATE on the management of neuroendocrine tumors.

Conditions

Neuroendocrine Tumors

Keywords

NET; neuroendocrine tumors; somastostatin receptor; PET; DOTATATE

Outcome Measures

Primary Outcomes (1)

• Change in intended management of patients with NETs after PET/CT

  The study will collect questionnaire data from referring physicians on intended patient management before and after PET/CT.

  Before the first scan and after the second scan and results reported

Study Arms (1)

PET/CT with one-time administration of 68Ga-DOTATATE

EXPERIMENTAL

Study participants will receive a one-time administration of 68Ga-DOTATATE and undergo a PET/CT imaging study. Scans will be performed with oral and IV contrast. The physicians of patient's receiving a 68Ga-DOTATATE PET/CT will be asked to fill out 2 questionnaires with questions pertaining to the patient's medical management. One questionnaire will be sent before the scan, and one shortly after the scan was performed and the results reported to the referring physician.

Drug: 68Ga-DOTATATE

Interventions

68Ga-DOTATATE DRUG

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

Also known as: 68Ga-DOTATATE PET/CT scan

PET/CT with one-time administration of 68Ga-DOTATATE

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 NET, suspected SSTR positive tumors or suspected NET recurrence.
• At least 18 years of age.
• Patient or patient's legally acceptable representative cognitively provides written informed consent.
• Able to provide informed consent.
• Females of childbearing potential must have a negative pregnancy test at screening/baseline.

You may not qualify if:

• 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.
• 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

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California Los Angeles, Nuclear Medicine Clinic of the Department of Molecular and Medical Pharmacology

Los Angeles, California, 90095, United States

Location

Related Publications (11)

• Modlin IM, Moss SF, Chung DC, Jensen RT, Snyderwine E. Priorities for improving the management of gastroenteropancreatic neuroendocrine tumors. J Natl Cancer Inst. 2008 Sep 17;100(18):1282-9. doi: 10.1093/jnci/djn275. Epub 2008 Sep 9.

  PMID: 18780869 BACKGROUND

• Modlin IM, Oberg K, Chung DC, Jensen RT, de Herder WW, Thakker RV, Caplin M, Delle Fave G, Kaltsas GA, Krenning EP, Moss SF, Nilsson O, Rindi G, Salazar R, Ruszniewski P, Sundin A. Gastroenteropancreatic neuroendocrine tumours. Lancet Oncol. 2008 Jan;9(1):61-72. doi: 10.1016/S1470-2045(07)70410-2.

  PMID: 18177818 BACKGROUND

• Yao JC, Hassan M, Phan A, Dagohoy C, Leary C, Mares JE, Abdalla EK, Fleming JB, Vauthey JN, Rashid A, Evans DB. One hundred years after "carcinoid": epidemiology of and prognostic factors for neuroendocrine tumors in 35,825 cases in the United States. J Clin Oncol. 2008 Jun 20;26(18):3063-72. doi: 10.1200/JCO.2007.15.4377.

  PMID: 18565894 BACKGROUND

• Rensing BJ, Hermans WR, Strauss BH, Serruys PW. Regional differences in elastic recoil after percutaneous transluminal coronary angioplasty: a quantitative angiographic study. J Am Coll Cardiol. 1991 May;17(6 Suppl B):34B-38B. doi: 10.1016/0735-1097(91)90936-4.

  PMID: 2016480 BACKGROUND

• Virgolini I, Ambrosini V, Bomanji JB, Baum RP, Fanti S, Gabriel M, Papathanasiou ND, Pepe G, Oyen W, De Cristoforo C, Chiti A. Procedure guidelines for PET/CT tumour imaging with 68Ga-DOTA-conjugated peptides: 68Ga-DOTA-TOC, 68Ga-DOTA-NOC, 68Ga-DOTA-TATE. Eur J Nucl Med Mol Imaging. 2010 Oct;37(10):2004-10. doi: 10.1007/s00259-010-1512-3.

  PMID: 20596866 BACKGROUND

• Kowalski J, Henze M, Schuhmacher J, Macke HR, Hofmann M, Haberkorn U. Evaluation of positron emission tomography imaging using [68Ga]-DOTA-D Phe(1)-Tyr(3)-Octreotide in comparison to [111In]-DTPAOC SPECT. First results in patients with neuroendocrine tumors. Mol Imaging Biol. 2003 Jan-Feb;5(1):42-8. doi: 10.1016/s1536-1632(03)00038-6.

  PMID: 14499161 BACKGROUND

• Hofmann M, Maecke H, Borner R, Weckesser E, Schoffski P, Oei L, Schumacher J, Henze M, Heppeler A, Meyer J, Knapp H. Biokinetics and imaging with the somatostatin receptor PET radioligand (68)Ga-DOTATOC: preliminary data. Eur J Nucl Med. 2001 Dec;28(12):1751-7. doi: 10.1007/s002590100639. Epub 2001 Oct 31.

  PMID: 11734911 BACKGROUND

• Gabriel M, Decristoforo C, Kendler D, Dobrozemsky G, Heute D, Uprimny C, Kovacs P, Von Guggenberg E, Bale R, Virgolini IJ. 68Ga-DOTA-Tyr3-octreotide PET in neuroendocrine tumors: comparison with somatostatin receptor scintigraphy and CT. J Nucl Med. 2007 Apr;48(4):508-18. doi: 10.2967/jnumed.106.035667.

  PMID: 17401086 BACKGROUND

• Putzer D, Gabriel M, Henninger B, Kendler D, Uprimny C, Dobrozemsky G, Decristoforo C, Bale RJ, Jaschke W, Virgolini IJ. Bone metastases in patients with neuroendocrine tumor: 68Ga-DOTA-Tyr3-octreotide PET in comparison to CT and bone scintigraphy. J Nucl Med. 2009 Aug;50(8):1214-21. doi: 10.2967/jnumed.108.060236. Epub 2009 Jul 17.

  PMID: 19617343 BACKGROUND

• Prasad V, Ambrosini V, Hommann M, Hoersch D, Fanti S, Baum RP. Detection of unknown primary neuroendocrine tumours (CUP-NET) using (68)Ga-DOTA-NOC receptor PET/CT. Eur J Nucl Med Mol Imaging. 2010 Jan;37(1):67-77. doi: 10.1007/s00259-009-1205-y.

  PMID: 19618183 BACKGROUND

• Ambrosini V, Tomassetti P, Franchi R, Fanti S. Imaging of NETs with PET radiopharmaceuticals. Q J Nucl Med Mol Imaging. 2010 Feb;54(1):16-23.

  PMID: 20168283 BACKGROUND

Related Links

• Ahmanson Imaging Division
• Department of Molecular and Medical Pharmacology UCLA

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

gallium Ga 68 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Johannes Czernin, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 10, 2013
• Study Start: August 26, 2013
• Primary Completion: June 16, 2017
• Study Completion: June 16, 2017
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)