A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors
A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors
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.
This research study is a Pilot Study, which is the first time investigators are examining
 this study intervention.

 Many patients who are diagnosed with carcinoid tumor undergo treatment with long acting
 release (LAR) octreotide. It is presently standard for all patients to receive equal doses of
 octreotide. However, the response to the treatment with the same dose of medication may vary
 substantially from one person to another. This study uses a novel form of PET/MR imaging to
 try and better understand how to treat carcinoid tumors, and may in the future allow doctors
 to tailor treatment dosing based on PET/MR findings and select the right drug dose for an
 individual person. It is important to note that the participant method of treatment and the
 dose of the participant medication (Octreotide LAR) will not change in this study.

 The imaging technique used in this study is called Ga-68-DOTA-TOC PET/MR scanning.
 Ga-68-DOTA-TOC is a radioactive tracer that is given by vein to participants before PET
 scanning. The scanner then detects radioactivity from the tracer that is attached to cells
 within the body and uses this information to create images (pictures) on a computer screen
 that can then be analyzed.

 These types of scans are investigational. "Investigational", meaning that the scans are still
 being studied and that research doctors are trying to find out more about them. It also means
 that the FDA (U.S. Food and Drug Administration) has not approved these types of PET scans
 for this type of cancer.
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