NCT02358018

Brief Summary

The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan, instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor. 68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the USA, with better tumor detection than with OctreoScan.

Trial Health

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Trial Health Score

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

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

February 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

First QC Date

February 3, 2015

Last Update Submit

November 1, 2016

Conditions

Neuroendocrine Tumors

Keywords

68Ga-DOTATOCPET/CT scan14-226

Interventions

68Ga-DOTATOC PET/CT ScanDRUG

Study participants will undergo the 68Ga-DOTATOC PET/CT after informed consent. The nominal injected dose will be up 3-5.5 mCi containing approximately 10 - 50 microgram of 68Ga-DOTATOC and will be injected via IV access lines. CT scans will be performed with our standard oral contrast agent (typically Omnipaque and/or barium) in accordance with our standard FDG practice unless some contraindication is present. Uptake period following injection will be 0.75-1hour. Acquisition time will be approximately \~1 hour. In patients who may not be able to lie still, anesthesia will be provided as per routine standard clinical practice.

Eligibility Criteria

Age5 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed or suspected NET requiring 111In-pentetreotide imaging for clinical indications.
  • High risk of NET because of familial predisposition with clinical findings requiring radiolabeled somatostatin imaging.
  • Other somatostatin positive tumor for which 111In-pentetreotide has been used successfully (for example adult meningioma).
  • Ability of subject or Legally Authorized Representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent.

You may not qualify if:

  • Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be performed if expected risk outweighs the benefit. Pregnancy testing will follow MITS procedure for diagnostic reagents. Patients self report pregnancy status. If pregnant the test will not be performed unless in the clinical opinion of the attending physician the gain of the test is likely to outweigh the risk (this will be rare). If unsure whether pregnant or not then a urine or serum pregnancy will be performed.
  • Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATOC in the mother, breastfeeding should be discontinued for at least one day if the mother receives 68Ga-DOTATOC.
  • Patients that have contraindications for 111In-pentetreotide.
  • Known severe allergy or hypersensitivity to oral contrast will preclude administration of such contrast (will preclude receiving oral contrast only).
  • 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.
  • 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)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Neuroendocrine Tumors

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Ravinder Grewal, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2015

First Posted

February 6, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

US(1)