Clinical Trial · NCT03057509

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

Overview

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.

Sponsor

Massachusetts General Hospital

Phase

Phase 1

Contacts

Umar Mahmood, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03057509

Drug / Compound

DOTATOC

Isotope(s):

Target(s):

SSTR2

Ligand Class: Peptides

Chelator: DOTA

Eligibility

Inclusion

Receiving a stable dose of octreotide LAR as a part of a treatment regimen for ≥3months
Have histologically or cytologically confirmed small bowel carcinoid tumor
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.
Presently planned for ongoing octreotide according to current standard of care for at least 18 months (i.e. throughout the study follow-up period).
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.

Exclusion

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.
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 allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biologic composition to Ga-68-DOTA-TOC used in study.
History of Meniere's disease
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.
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.
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.