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