Development of a Short-Acting GH Suppression Test with subcutaneous short action Pasireotide (PAT) for Predicting Long-Term Response to Pasireotide LAR in Patients with Acromegaly

Conditions

Acromegaly

Brief summary

GH concentration cut-off value(s) at 2 and/or 3 hours after administration of subcutaneous pasireotide that best discriminate responders from non-responders to pasireotide LAR.

Detailed description

Determination of IGF-1 levels at 10 minutes before administration of pasireotide LIAM 0.3 mg on Day 1, and at 10 minutes before administration of pasireotide LIAM 0.6 mg on Day 4., Determination of pasireotide LIAM blood concentrations at -10 minutes, 0 hours, 1 hour, 2 hours, and 3 hours following administration of pasireotide LIAM 0.3 mg on Day 1, and at -10 minutes, 0 hours, 1 hour, 2 hours, and 3 hours following administration of pasireotide LIAM 0.6 mg on Day 4., Assessment of the influence of confounding factors on GH cutoff values predictive of response to the test at diagnosis and throughout the study (3 months of follow up)., Correlation between GH suppression in the acute pasireotide test and T2 MRI tumor signal intensity.

Related papers

No related papers found yet.

Interventions

DRUGPASIREOTIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
GH concentration cut-off value(s) at 2 and/or 3 hours after administration of subcutaneous pasireotide that best discriminate responders from non-responders to pasireotide LAR.	—

Secondary

Measure	Time frame
Determination of IGF-1 levels at 10 minutes before administration of pasireotide LIAM 0.3 mg on Day 1, and at 10 minutes before administration of pasireotide LIAM 0.6 mg on Day 4., Determination of pasireotide LIAM blood concentrations at -10 minutes, 0 hours, 1 hour, 2 hours, and 3 hours following administration of pasireotide LIAM 0.3 mg on Day 1, and at -10 minutes, 0 hours, 1 hour, 2 hours, and 3 hours following administration of pasireotide LIAM 0.6 mg on Day 4., Assessment of the influence of confounding factors on GH cutoff values predictive of response to the test at diagnosis and throughout the study (3 months of follow up)., Correlation between GH suppression in the acute pasireotide test and T2 MRI tumor signal intensity.	—

Measure

Time frame

Determination of IGF-1 levels at 10 minutes before administration of pasireotide LIAM 0.3 mg on Day 1, and at 10 minutes before administration of pasireotide LIAM 0.6 mg on Day 4., Determination of pasireotide LIAM blood concentrations at -10 minutes, 0 hours, 1 hour, 2 hours, and 3 hours following administration of pasireotide LIAM 0.3 mg on Day 1, and at -10 minutes, 0 hours, 1 hour, 2 hours, and 3 hours following administration of pasireotide LIAM 0.6 mg on Day 4., Assessment of the influence of confounding factors on GH cutoff values predictive of response to the test at diagnosis and throughout the study (3 months of follow up)., Correlation between GH suppression in the acute pasireotide test and T2 MRI tumor signal intensity.

—

Outcome results

None listed