NCT02359500

Brief Summary

This study plans to demonstrate the safety and efficacy of \[68Ga\]-DOTA-tyr3-Octreotide (\[68Ga\]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of response to treatment in patients with Somatostatin receptor expressing tumors who undergo imaging with a clinical indication. The investigators will conduct a study for 68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors. 68Ga-DOTATOC will be used in diagnostic assessment of patients with known or suspected NETs for whom there is an appropriate standard clinical indication for 68Ga-DOTATOC PET/CT either at staging or during follow up.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

2.1 years

First QC Date

January 23, 2015

Last Update Submit

May 1, 2017

Conditions

Neuroendocrine TumorsCarcinoid Tumors

Keywords

68Ga- DOTATOCDiagnosisSomatostatin Receptor-Positive Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • Change in size of lesion

    Change in size of lesion at 1 month as compared to baseline

    baseline and 1 month

Secondary Outcomes (3)

  • Incidence of new lesions

    baseline and 1 month

  • Incidence of change in treatment

    baseline and 1 month

  • Incidence of previously unknown primary tumor

    baseline and 1 month

Study Arms (1)

68Ga-DOTATOC PET

EXPERIMENTAL

patients with known or suspected somatostatin receptor positive neuroendocrine tumors (NETs)

Drug: 68Ga-DOTATOC PET

Interventions

68Ga-DOTATOC PETDRUG

68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors.

Also known as: [68Ga]-DOTA-tyr3-Octreotide, [68Ga]-DOTATOC
68Ga-DOTATOC PET

Eligibility Criteria

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

You may qualify if:

  • Known or suspected somatostatin receptor positive NETs (e.g. carcinoid, pancreatic neuroendocrine tumors, and pheochromocytoma). Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
  • Karnofsky performance status of ≥50 (or ECOG/WHO equivalent)
  • Off Sandostatin (octreotide acetate)-long acting release (LAR) \> 4 weeks and off immediate release (subcutaneous) for at least 12 hrs prior to 68Ga-DOTATOC PET-CT imaging
  • Able to provide informed consent
  • At least 18 years of age

You may not qualify if:

  • Pregnancy or breast feeding. A negative serum pregnancy test is required for all female subjects with child- bearing potential
  • Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed
  • Medical condition uncontrolled by treatment making completion of study unlikely
  • Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET/CT scanner due to Body Mass Index (BMI)
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g. severe claustrophobia)
  • Any additional medical condition, serious intercurrent illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Neuroendocrine TumorsCarcinoid TumorDisease

Interventions

Ga(III)-DOTATOC

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lale Kostakoglu, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Nuclear Medicine and Molecular Imaging

Study Record Dates

First Submitted

January 23, 2015

First Posted

February 10, 2015

Study Start

December 1, 2014

Primary Completion

January 23, 2017

Study Completion

January 23, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

US(1)