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Imaging Techniques for Cushing 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
Age 18-80
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months
Awards & highlights

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.

Who is the study for?
Adults aged 18-80 with suspected ectopic Cushing syndrome, able to return for follow-up. Excludes pregnant/lactating women, those over 136 kg, under 18 or over 90 years old, severe infections/allergies to somatostatin analogues, certain medication users (affecting CYP3A4), and patients with significant heart, blood, liver or kidney issues.Check my eligibility
What is being tested?
The trial is testing the effectiveness of PET/CT scans using two substances (68Ga-DOTATATE and F-DOPA) compared to routine MRI in locating the source of ACTH causing ectopic Cushing syndrome. It also evaluates if mifepristone improves PET/CT scan sensitivity.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the imaging agents used during scans. Mifepristone can cause changes in menstrual cycle, fatigue, headache and dizziness among other symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I might have Cushing syndrome not caused by a pituitary tumor.
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I am between 18 and 80 years old.
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I am willing to go back to NIH for follow-up studies.

Timeline

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
To determine if there is a combination of imaging tests with optimal diagnostic accuracy.
To determine which imaging technique (F-DOPA PET/CT, 68Ga-DOTATATE PET/CT, CT, and/or MRI) has the best sensitivity.
Secondary outcome measures
To evaluate a potential correlation between 18F-DOPA or 68Ga-DOTATATE uptake and the type of tumor, its size, SSTR expression or proliferative activity.

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
18F-DOPA
2017
Completed Phase 3
~2080
68Ga-DOTATATE
2013
Completed Phase 2
~240
CT scan
2017
Completed Phase 2
~2360

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,956 Previous Clinical Trials
2,672,274 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
2,348 Previous Clinical Trials
4,314,652 Total Patients Enrolled
Lynnette K Nieman, M.D.Principal InvestigatorEunice 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
~32 spots leftby Dec 2030