Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
| Status: | Available |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any - 64 |
| Updated: | 4/21/2016 |
| Contact: | Victor Seghers, PhD, MD |
| Email: | vjsegher@texaschildrens.org |
| Phone: | 832-822-0429 |
Phase II Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide
improved presurgical planning and distinguish between focal and diffuse forms of HI. The
investigators will perform descriptive analysis, relying on visual analysis to diagnose and
localize a focal lesion. Our findings will be compared to surgical histopathology to
determine sensitivity and specificity or this technique. The investigators will also track
patient surgical outcomes, specifically whether the patient is surgically "cured" or still
requires medical management to control residual hypoglycemia.
improved presurgical planning and distinguish between focal and diffuse forms of HI. The
investigators will perform descriptive analysis, relying on visual analysis to diagnose and
localize a focal lesion. Our findings will be compared to surgical histopathology to
determine sensitivity and specificity or this technique. The investigators will also track
patient surgical outcomes, specifically whether the patient is surgically "cured" or still
requires medical management to control residual hypoglycemia.
Hyperinsulinemic hypoglycemia is caused by low glucose due to excessive insulin secretion
and remains difficult to treat because of the requirement for extensive amounts of glucose
and the lack of effective long-term medical therapy. Correct diagnosis, localization, and
limited excision of the focal lesion will result in a complete cure of the patient. In
contrast, medically unresponsive diffuse disease requires a near total pancreatectomy,
greatly increasing the risk of future diabetes mellitus. Fortunately, [18F]-DOPA PET has
been shown to be a useful noninvasive imaging method for distinguishing between focal and
diffuse forms of hyperinsulinemic hypoglycemia. In this study, the investigators seek to
validate the effectiveness of using PET/MR and PET/CT with F-DOPA to accurately and reliably
detect and localize disease.
and remains difficult to treat because of the requirement for extensive amounts of glucose
and the lack of effective long-term medical therapy. Correct diagnosis, localization, and
limited excision of the focal lesion will result in a complete cure of the patient. In
contrast, medically unresponsive diffuse disease requires a near total pancreatectomy,
greatly increasing the risk of future diabetes mellitus. Fortunately, [18F]-DOPA PET has
been shown to be a useful noninvasive imaging method for distinguishing between focal and
diffuse forms of hyperinsulinemic hypoglycemia. In this study, the investigators seek to
validate the effectiveness of using PET/MR and PET/CT with F-DOPA to accurately and reliably
detect and localize disease.
Inclusion Criteria:
- All Patients clinically diagnosed with Hyperinsulinemia of any age
- Patients in need of PET scan
- Patients that require sedation
- Patients that do not require sedation
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
- Patients without Hyperinsulinemia
- Patients who are or may be pregnant
- Serious intercurrent medical illness other than hypoglycemia that precludes having
the scan either because of patient instability or concerns about potential toxicity.
- Patient's requiring emergency surgical intervention that would be inappropriately
delayed by [18F]-DOPA PET imaging.
We found this trial at
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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