Clinical trial NCT03057509 (phase 1, status: withdrawn)
Conditions: small bowel carcinoid tumor
ICD codes: C7A.00, C7A.010, C7A.011, C7A.012, C7A.020, C7A.021, C7A.026
Drugs: ga-68-dota-toc, lar octreotide
SMILES: [H][C@]1(NC(=O)[C@H](CCCCN)NC(=O)[C@@H](CC2=CNC3=C2C=CC=C3)NC(=O)[C@H](CC2=CC=CC=C2)NC(=O)[C@H](CSSC[C@H](NC1=O)C(=O)N[C@H](CO)[C@@H](C)O)NC(=O)[C@H](N)CC1=CC=CC=C1)[C@@H](C)O
Reason stopped: 
    slow accrual
  
Eligibility criteria:

        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