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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
Age 18-80
Be older than 18 years old
Must not have
Clinically significantly impaired cardiovascular (e.g. history of abnormally low ejection fraction, the presence of moderate pulmonary fluid overload, and/or blood pressure over 190/100), abnormal coagulation in the absence of medically-indicated treatment (PT and PTT elevated by 30% above the normal values), hematopoietic (hematocrit less than 30%, hemoglobin below 10 g/dl, white count below 3000 K/UL, and platelets below 100,000 K/mm(3)), hepatic (liver enzymes elevated by 4-fold above normal values), or renal function (plasma creatinine level over 2.1)
Very elderly patients (> 90 years)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-12 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have significant heart, blood, liver, or kidney problems.
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I am over 90 years old.
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I am currently fighting a severe infection.
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I am allergic to certain imaging agents or cancer drugs.
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I am able to understand and give consent for my treatment.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.

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 Early Phase 1
~100
18F-DOPA
2017
Completed Phase 3
~2080
CT scan
2013
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
2,055 Previous Clinical Trials
2,731,814 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Lead Sponsor
2,448 Previous Clinical Trials
4,332,339 Total Patients Enrolled
Lynnette K Nieman, M.D.Principal InvestigatorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
13 Previous Clinical Trials
3,947 Total Patients Enrolled

Media Library

DOTATATE PET-CT Clinical Trial Eligibility Overview. Trial Name: NCT02019706 — Phase 2
Adrenocorticotropic Hormone Research Study Groups: Imaging
Adrenocorticotropic Hormone 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
~29 spots leftby Dec 2030
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