DOTATATE PET-CT for Cushing's Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, MD
Cushing's Syndrome+3 More
DOTATATE PET-CT - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a radioactive chemical may be used to detect tumors which cause Cushing syndrome.

See full description

Eligible Conditions

  • Cushing's Syndrome
  • ACTH

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cushing's Syndrome

Study Objectives

This trial is evaluating whether DOTATATE PET-CT will improve 2 primary outcomes and 2 secondary outcomes in patients with Cushing's Syndrome. Measurement will happen over the course of Ongoing.

6-12 months
Is there a combination of tests with optimal diagnostic accuracy?
Which imaging technique best detects ectopic ACTH-producing tumors
Ongoing
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cushing's Syndrome

Trial Design

1 Treatment Group

Imaging
1 of 1
Experimental Treatment

This trial requires 80 total participants across 1 different treatment group

This trial involves a single treatment. DOTATATE PET-CT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

ImagingAll subjects will be imaged
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CT scan
2017
Completed Phase 2
~2290
18F-DOPA
2017
Completed Phase 3
~2080
68Ga-DOTATATE
2013
Completed Phase 2
~240

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6-12 months for reporting.

Closest Location

National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adults with possible ectopic Cushing syndrome
Age 18-80
Patients must be willing to return to NIH for follow-up studies.

Patient Q&A Section

What causes cushing syndrome?

"The exact underlying mechanism is still unknown, as well as the factors that activate this syndrome. However, the cushing hormones, ACTH and cortisol do play an important role in the cushing syndrome. Patients with these hormones must be treated in order to avoid severe complications of CS." - Anonymous Online Contributor

Unverified Answer

What is cushing syndrome?

"Cushing-related adrenal insufficiency occurs in about half a million women and 25–50% of men aged 50 and older, as part of normal aging. Symptoms of Cushing-related adrenal insufficiency include weight changes, increased fatigue, muscle aches, joint pains, weakness, and problems concentrating and memory. More serious, sometimes life-threatening, symptoms include high blood glucose, low blood potassium and loss of blood pressure and heart rate that can lead to fainting, convulsions, and death without treatment. The hypothalamic-pituitary-adrenal axis regulates the body's immune system and stress, in part by secreting hormones that modify the body's physiology." - Anonymous Online Contributor

Unverified Answer

Can cushing syndrome be cured?

"This review concludes cushing syndrome can be successfully treated with long-term glucocorticoid replacement therapy. The success rate is high (90%). Despite recent advances in glucocorticoid replacement therapy, long-term glucocorticoid replacement therapy remains one of the best available treatments for treatment of CS in most patients." - Anonymous Online Contributor

Unverified Answer

What are the signs of cushing syndrome?

"As many as one fifth of the community sample had a clinical diagnosis of hypercorticosteroidism. This is an important and neglected disorder; thus a simple clinical history and measurement would be very helpful in early diagnosis. The prevalence of hypothyroidism was higher than expected (10-20 % vs 5-10 %), whereas the prevalence of Cushing syndrome was lower than expected." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cushing syndrome?

"Cushing syndrome is a complex condition and requires individualized treatments. Common interventions can include medication, surgery, chemotherapy or radiation therapy. However, all treatments to alleviate symptoms and correct the underlying hypercortisolism are needed. In severe and refractory cases, it is necessary to discuss the possibility of radioactive adrenalectomy or bilateral adrenalectomy. These alternative treatments can improve quality of life for patients. Appropriate social support is vital for patients with hypercortisolism, since mental distress can often be exacerbated by the condition." - Anonymous Online Contributor

Unverified Answer

How many people get cushing syndrome a year in the United States?

"About 28,000 US children are diagnosed with Cushing syndrome a year; a significant percentage of cases being missed. This makes up one out of twenty-one children." - Anonymous Online Contributor

Unverified Answer

Is dotatate pet-ct safe for people?

"The dotatate pet-ct is suitable for patients who have severe or refractory hypercalcemia due to metastatic or indolent carcinoma(s) of the parathyroid gland, breast, or multiple endocrine tumors." - Anonymous Online Contributor

Unverified Answer

Has dotatate pet-ct proven to be more effective than a placebo?

"We conclude that a 6-week treatment with dotatate pet-ct is effective in the treatment of gastric adenocarcinomas, especially in patients with c-KIT overexpression, and may be a better alternative to current standard therapies." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets cushing syndrome?

"If you're a woman, you have a higher chance of getting cushing syndrome in your 50s and 60s. If this is your age group, contact your doctor or ask a nurse if you suspect you might have it later in life. A healthy lifestyle can help postpone and/or decrease the date that Cushing's happens in your life." - Anonymous Online Contributor

Unverified Answer

What does dotatate pet-ct usually treat?

"In the last 15 years the number of PET/CT applications has doubled every 3 years, thus the number of indications has also doubled in the same time span. Among others the first indications should be excluded benign tumors and the second should be FDG PET/CT in primary staging of tumor of unknown origin. Results from a recent paper points out a significant improvement of the diagnostic accuracy on the basis of DPT PET/CT in comparison with classical imaging, mainly in the patients with thyroid nodule on the first line." - Anonymous Online Contributor

Unverified Answer

Does dotatate pet-ct improve quality of life for those with cushing syndrome?

"DPCT can be an alternative for TIO management, improving QoL of patients with cNS, especially for those with hCG >1000 mIU/L. However, this therapy should be carefully prescribed to ensure no adverse side effect such as hypotension caused by hypervolemic hyponatremia." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in dotatate pet-ct for therapeutic use?

"Recent developments in dotatate pet-ct, especially with the use of dotatase in the formulation, is promising and has the potential to make a substantial impact on cancer management in future years." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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