Clinical trial NCT03057509: A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors
Official title: A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Small Bowel Carcinoid Tumor
Keywords: Carcinoid Tumors
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: Mean Change in SUVmax
timeFrame: 2 years
measure: Mean Change in Total Molecular Burden of The Lesions
timeFrame: 2 Years
Secondary outcomes:
measure: Correlation Of Change In Receptor Occupancy With The PFS of patients
timeFrame: 2 years
measure: Progression Free Survival Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts general Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Umar Mahmood, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: