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

NCT03057509 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 16-193
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Small Bowel Carcinoid Tumor

Keywords

Carcinoid Tumors

Outcome Measures

Primary Outcomes (2)

• Mean Change in SUVmax

  The mean change of SUVmax from 68Ga-DOTATOC PET scan obtained at peak and trough octreotide LAR therapy.

  2 years

• Mean Change in Total Molecular Burden of The Lesions

  The mean change of Total Molecular Tumor Burden is measured from 68Ga-DOTATOC PET scan obtained at peak and trough octreotide LAR therapy.

  2 Years

Secondary Outcomes (2)

• Correlation Of Change In Receptor Occupancy With The PFS of patients

  2 years

• Progression Free Survival Rate

  2 years

Study Arms (1)

Gallium PET/MR Imaging

EXPERIMENTAL

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: Ga-68-DOTA-TOC; Device: Siemens PET/MR scanner; Other: Standard Siemens Software; Drug: LAR Octreotide

Interventions

Ga-68-DOTA-TOC DRUG

Ga-68-DOTA-TOC is a imaging radiotracer that is used for positron emission tomography imaging of a variety of the neuroendocrine tumors. This radiotracer in the body binds to several subtypes of the somatostatin receptor and accumulates in the tissue with high expression of these receptors. Therefore neuroendocrine tumors that express somatostatin receptors can be imaged using this radiotracer.

Gallium PET/MR Imaging

Siemens PET/MR scanner DEVICE

Positron emission tomography-magnetic resonance (PET/MR) is a hybrid imaging technology that incorporates magnetic resonance imaging (MRI) soft tissue morphological imaging and positron emission tomography (PET) functional imaging. The Siemens PET/MR system (Biograph mMR) received a CE mark and FDA approval for clinical diagnostic imaging.

Gallium PET/MR Imaging

Standard Siemens Software OTHER

The Siemens PET/MR scanner are equipped with a standard clinical visualization software with the advanced application tools based on the Siemens image interpretation engine called syngo.via. This software allows for visualization and interpretation of the image data-sets in the clinical environment.

Gallium PET/MR Imaging

LAR Octreotide DRUG

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.

Also known as: Sandostatin

Gallium PET/MR Imaging

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Carcinoid Tumor

Interventions

gallium Ga 68 dotatate; Octreotide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Umar Mahmood, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 20, 2017
• Study Start: November 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: September 30, 2021
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)