DOTATATE PET-CT for Cushing's Syndrome

Phase 2

Recruiting

Led By Lynnette K Nieman, M.D.

Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults with possible ectopic Cushing syndrome

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up6-12 months

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing whether a certain imaging technique can help doctors better locate the source of a hormone that is produced in excess in people with Cushing syndrome, and whether a medication can improve the accuracy of the imaging.

Eligible Conditions

Cushing's Syndrome
Adrenocorticotropic Hormone

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Select...

You are an adult who might have a condition called ectopic Cushing syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Is there a combination of tests with optimal diagnostic accuracy?

Which imaging technique best detects ectopic ACTH-producing tumors

Secondary outcome measures

Is there a correlation between F-DOPA or DOTATATE uptake and type of tumor, size and proliferative activity

Number lesions detected by gated chest MRI vs. routine MRI

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ImagingExperimental Treatment7 Interventions

All subjects will be imaged

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

68Ga-DOTATATE

2013

Completed Phase 2

~240

18F-DOPA

2017

Completed Phase 3

~2080

CT scan

2017

Completed Phase 2

~2360

0 / 1Eligibility criteria met

Find a site

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor

1,901 Previous Clinical Trials

2,199,057 Total Patients Enrolled

5 Trials studying Cushing's Syndrome

4,224 Patients Enrolled for Cushing's Syndrome

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,258 Previous Clinical Trials

4,200,366 Total Patients Enrolled

Lynnette K Nieman, M.D.Principal Investigator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

12 Previous Clinical Trials

3,807 Total Patients Enrolled

3 Trials studying Cushing's Syndrome

587 Patients Enrolled for Cushing's Syndrome

Media Library

DOTATATE PET-CT Clinical Trial Eligibility Overview. Trial Name: NCT02019706 — Phase 2

Cushing's Syndrome Research Study Groups: Imaging

Cushing's Syndrome Clinical Trial 2023: DOTATATE PET-CT Highlights & Side Effects. Trial Name: NCT02019706 — Phase 2

DOTATATE PET-CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT02019706 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction for inclusion in this research?

"This medical study is accepting participants aged 18 to 80. There are 373 studies dedicated to underage individuals and 986 for those over 65 years of age."

Answered by AI

Are there still available slots for interested enrollees in this research?

"As seen on clinicaltrials.gov, this study is actively seeking participants and was initially written up on February 12th 2014 with the last edit taking place September 7th 2022."

Answered by AI

Has the FDA greenlighted DOTATATE PET-CT for general use?

"Our assessment at Power is that DOTATATE PET-CT has an approximate safety rating of 2. This evaluation takes into account the fact that this Phase 2 trial holds some evidence for safety, but lacks any substantive proof of efficacy."

Answered by AI

For what volume of individuals is this clinical trial enrolling?

"Affirmative. The clinical trial database on ClinicalTrials.gov states that this research endeavour, posted initially in February of 2014 and edited as recently as September 2022, is actively searching for 80 participants from two distinct areas."

Answered by AI

Would I qualify to partake in this research project?

"This medical trial is searching for 80 individuals with Cushing's Syndrome, ranging from 18 to 80 years old. Moreover, participants must be willing to return to the NIH for subsequent testing sessions."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing Syndrome

2014. "Evaluation of 68Ga-DOTATATE PET/CT, Octreotide and F-DOPA PET Imaging in Patients With Ectopic Cushing Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02019706.