Gallium Ga 68-Edotreotide PET/MRI in Imaging Patients with Small Bowel Tumors
This pilot phase I trial studies how well gallium Ga 68-edotreotide positron emission tomography (PET)/magnetic resonance imaging (MRI) works in imaging patients with small bowel tumors. Diagnostic procedures, such as gallium Ga 68-edotreotide PET/MRI, may help find and diagnose small bowel tumors.
Inclusion Criteria
- Have histologically or cytologically confirmed small bowel carcinoid tumor
- Receiving a stable dose of octreotide LAR as a part of a treatment regimen for >= 3 months
- Presently planned for ongoing octreotide according to current standard of care for at least 12 months (i.e. throughout the study follow-up period)
- Presently planned for restaging using contrast-enhanced computed tomography (CT) scans at baseline and at least every 6 months, as a part of their standard of care assessments
- 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
- History of allergic reactions to IV contrasts or reactions attributed to compounds of similar chemical or biologic composition to Ga-68-DOTA-TOC or 18F-FLT 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; breastfeeding mothers are also excluded from this study
- Expected lifespan less than 12 months by investigator assessment
- Previous hypersensitivity reaction to LAR octreotide
- Non-removable hearing aid or dentures, metal intrauterine device (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03057509.
PRIMARY OBJECTIVES:
I. To preliminarily estimate the treatment-induced percent change in the unoccupied somatostatin receptor fractions by measurement of the gallium Ga 68-edotreotide (Ga-68-DOTA-TOC) uptake in the carcinoid tumors at peak (around 14 days post injection) and trough (around 28 days post injection) circulating levels after standard long-acting release (LAR) octreotide dosing, and correlate this value to 1 year progression free survival.
SECONDARY OBJECTIVES:
I. Calculate the percent change in total molecular tumor index burden between peak dosing and trough dosing as measured with whole body Ga-68-DOTA-TOC PET scan images.
II. Measure the tumor proliferation rate at trough dosing using the proliferation marker fluorothymidine F-18 (18F-FLT) PET as a downstream readout of the effectiveness of therapy (around 28 days post standard LAR injection).
OUTLINE:
Patients receive gallium Ga 68-edotreotide intravenously (IV) and undergo PET/MRI over 30 minutes at 28 days after standard of care LAR octreotide treatment, and then 14 days after the next standard of care LAR octreotide treatment.
After completion of study, patients are followed up periodically.
Trial PhasePhase I
Trial Typediagnostic
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorUmar Mahmood
- Primary ID16-193
- Secondary IDsNCI-2017-01746
- ClinicalTrials.gov IDNCT03057509