A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors (NCT03057509) | Clinical Trial Compass
WithdrawnPhase 1
A Pilot Study Of Ga-68-DOTA-TOC Imaging In Participants With Small Bowel Carcinoid Tumors
Stopped: Slow accrual
United States0Started 2018-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Mean Change in SUVmax
Timeframe: 2 years
2
Mean Change in Total Molecular Burden of The Lesions