Clinical Trial - NCT03057509

A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors

Recruiting

Sponsor: Massachusetts General Hospital

Collaborators:

Information provided by (Responsible party): Principal Investigator Massachusetts General Hospital Umar Mahmood Professor of Radiology

ClinicalTrials.gov Identifier: NCT03057509

Protocol Info

Short Description: Ga-68-DOTA-TOC IMAGING IN CARCINOID TUMORS
Long Description: A pilot study of Ga-68-DOTA-TOC imaging in participants with small bowel carcinoid tumors.
MGH Status: Open
Sponsor: DF/HCC
Disease Program: GI

Next Steps


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Purpose

This research study is designed to evaluate a type of scan called Ga-68-DOTA-TOC positron emission tomography (PET) scanning as a way of assessing carcinoid tumors.
Condition Title Intervention Phase
Small Bowel Carcinoid Tumor Ga-68-DOTA-TOC Siemens PET/MR scanner Standard Siemens Software LAR Octreotide Phase 1
Study Type Interventional
Official Title A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors

Primary Outcome Measures

Mean Change in SUVmax [Time Frame: 2 years] [Designated as safety issue: ]

Mean Change in Total Molecular Burden of The Lesions [Time Frame: 2 Years] [Designated as safety issue: ]


Secondary Outcome Measures

Correlation Of Change In Receptor Occupancy With The PFS of patients [Time Frame: 2 years] [Designated as safety issue: ]

Progression Free Survival Rate [Time Frame: 2 years] [Designated as safety issue: ]

Estimated Enrollment: 30
Study Start Date: November 2018
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: October 2019
Arms Assigned Interventions

Experimental:Gallium PET/MR Imaging

Siemens PET/MR scanner at Martinos Center for Biomedical Imaging will be use. Standard Siemens software will be used to perform image analysis and measure parameters such as SUVmean, SUVmax and MTV. Standard LAR Octreotide will be administered. Ga-68-DOTA-TOC that will be administered prior to PET/MR imaging at 7 days after standard LAR octreotide administration and again at 28 day. Ga-68-DOTA-TOC will be administered as a single intravenous dose at a pre-determine dosage.
Drug:LAR Octreotide
LAR octreotide is a man-made protein that is similar to a hormone in the body called somatostatin. LAR Octreotide lowers many substances in the body such as insulin and glucagon, growth hormone, and chemicals that affect digestion. LAR octreotide is used to treat a variety of clinical conditions but most importantly to reduce flushing episodes and watery diarrhea caused by cancerous tumors such as neuroendocrine tumors.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

Inclusion Criteria:

  • Age ≥ 18 years
  • Have histologically or cytologically confirmed small bowel carcinoid tumor
  • Receiving a stable dose of octreotide LAR as a part of a treatment regimen for ≥3months
  • Presently planned for ongoing octreotide according to current standard of care for at least 18 months (i.e. throughout the study follow-up period).
  • Presently planned for restaging using contrast-enhanced CT scans at baseline and at least every 6 months, as a part of their standard of care assessments.
  • The effects of Ga-68-DOTA-TOC on the developing human fetus are unknown. For this reason and because PET imaging agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of Ga-68-DOTA-TOC administration.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who have had radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biologic composition to Ga-68-DOTA-TOC used in study.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because Ga-68-DOTA-TOC have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of Ga-68-DOTA-TOC to mothers, breastfeeding mothers are also excluded from this study.
  • Expected lifespan less than 18 months by investigator assessment
  • Previous hypersensitivity reaction to LAR octreotide
  • Non-removable non-MR compatible placements including hearing aid or dentures, metal IUD, surgical aneurysm clips, cardiac pacemaker, prosthetic heart valve, neurostimulator, implanted pumps, cochlear implants, metal rods, plates or screws, surgery leaving implanted materials, metal injury to eye, metallic tattoos anywhere on the body, tattoos near the eye and transdermal patches
  • History of Meniere's disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT03057509

Locations

  • United States, Massachusetts
    • Massachusetts general Hospital Boston, Massachusetts, United States, 02114
    • Dana Farber Cancer Institute Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Massachusetts General Hospital

More Information

No publications provided

Responsible Party: Principal Investigator Massachusetts General Hospital Umar Mahmood Professor of Radiology
ClinicalTrials.gov Identifier: NCT03057509
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Massachusetts General Hospital:

Carcinoid Tumors

Additional relevant MeSH terms:

Carcinoid Tumor

Octreotide

Edotreotide

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on May 16, 2019