FET PET/CT Imaging for Cushing's Disease

BG
Overseen ByBrent Gessner, MBA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how effectively a special imaging test, called FET PET/CT, can detect a type of tumor in the pituitary gland that causes Cushing's disease. Cushing's disease results in the body producing excess hormones, leading to symptoms like weight gain and high blood pressure. The trial will assess whether this imaging can accurately identify the tumor before surgery. Individuals diagnosed with ACTH-dependent Cushing's disease who are planning surgery might be suitable candidates. As an Early Phase 1 trial, this study focuses on understanding the imaging test's function in people, offering participants an opportunity to contribute to groundbreaking research.

What prior data suggests that FET PET/CT imaging is safe for detecting ACTH-secreting pituitary adenoma?

A previous study used FET PET imaging to help identify pituitary adenomas, which are tumors in the pituitary gland. The research showed that patients tolerated this imaging method well, with no major side effects reported from the FET PET imaging itself. However, since this trial is in its earliest phase, the main focus remains on assessing the treatment's safety for humans. While the initial results appear promising, further information from this and future studies will help confirm the long-term safety of FET PET imaging.12345

Why are researchers excited about this trial?

Researchers are excited about FET PET/CT imaging for Cushing's disease because it offers a novel approach to pinpointing the source of excess hormone production in the body. Unlike standard treatments that often rely on surgery or medication to control hormone levels, this technique uses a special imaging agent, Fluoro-O-(2) fluoroethyl-L-tyrosine (FET), to create detailed scans of the pituitary gland. This can help doctors identify and target the precise areas affected by Cushing's disease, potentially leading to more effective and personalized treatment plans. Additionally, this method could reduce the need for invasive procedures and improve surgical outcomes by offering clearer insights into the disease's progression.

What evidence suggests that FET PET/CT imaging is effective for detecting ACTH-secreting pituitary adenoma in Cushing's disease?

Research has shown that FET PET/CT scans can help identify ACTH-secreting pituitary adenomas, which cause Cushing's disease. One study found that FET PET/MRI was highly effective at detecting small pituitary tumors. This trial will evaluate the effectiveness of FET PET/CT imaging in patients with ACTH-dependent Cushing's disease who may be candidates for surgical treatment. The imaging method will be compared to other techniques to distinguish Cushing's disease from other hormone-related issues. Past studies have demonstrated its usefulness in planning surgery for patients with hard-to-detect tumors. These early results suggest that FET PET/CT could be a promising tool for accurately diagnosing and planning treatment for Cushing's disease.12678

Who Is on the Research Team?

DJ

Derek Johnson, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

* Recent (within 3 months) pituitary MR, or pending pituitary MR to be performed as close as possible to FET PET/CT.
I have been diagnosed with ACTH-dependent Cushing disease by lab tests.
I have never had pituitary surgery.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo FET PET/CT imaging to detect ACTH-secreting pituitary adenoma

1 week
1 visit (in-person)

Surgical Evaluation

Participants may undergo surgical evaluation based on imaging results

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after imaging and potential surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: (ACTH)-dependent Cushing diseaseExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38514085/

[ 18 F]FET PET/MRI: An Accurate Technique for Detection ...

We here assess the diagnostic yield of O-(2-[18F]fluoroethyl)-l-tyrosine ([18F]FET) PET/MRI for detection of small functional pituitary tumors ...

Study Details | NCT07108244 | Use of [18F]FET PET-MRI ...

The purpose is to compare the diagnostic accuracy of these two modalities in distinguishing Cushing's disease from ectopic ACTH secretion. The results from both ...

FET PET/CT Imaging To Localize Pituitary Adenomas In ...

The purpose of this research is to evaluate the performance [sensitivity, specificity, accuracy] of FET PET/CT imaging to detect ACTH-secreting ...

FET PET/CT Imaging To Localize Pituitary Adenomas In ...

The purpose of this research is to evaluate the performance [sensitivity, specificity, accuracy] of FET PET/CT imaging to detect ACTH-secreting ...

The clinical value of [18F]-fluoro-ethyl-L-tyrosine PET ... - PMC

Retrospective observational cohort study of 34 patients with FPAs who underwent a total of 37 [18F]FET-PETs (Cushing's disease: n = 19, ...

FET PET/CT Imaging To Localize Pituitary Adenomas In ...

The purpose of this study is to evaluate the performance [sensitivity, specificity, accuracy] of 18Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET ...

18F‐fluoro‐ethyl‐tyrosine PET co‐registered with MRI in ...

An interindividual comparison of O-(2-[18F]fluoroethyl)-L-tyrosine (FET)- and L-[methyl-11C]methionine (MET)-PET in patients with brain gliomas ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41793555/

The clinical value of [18F]-fluoro-ethyl-L-tyrosine PET ...

The clinical value of [18F]-fluoro-ethyl-L-tyrosine PET ([18F]FET-PET) correlated with MRI in patients with functioning pituitary adenomas: ...