5 Participants NeededMy employer runs this trial

FET-PET/MRI for Pituitary Tumors

JS
Overseen ByJulia Santos
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 evaluate how effectively a new scan, FET-PET/MRI, can detect hidden pituitary tumors, which are growths in the small gland at the base of the brain. It targets individuals with conditions such as Cushing's Disease, Acromegaly, or elevated prolactin levels who may require surgery if a tumor is identified. Those who have confirmed these conditions through tests but whose MRI scans did not reveal a clear tumor might be suitable candidates for this study. The scan employs [18F] Fluoroethyl-L-tyrosine, a specialized imaging agent, to aid in tumor detection. As a Phase 1 trial, the research focuses on understanding how this new imaging method functions in people, offering participants the opportunity to be among the first to benefit from this innovative technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that FET-PET/MRI is safe for detecting pituitary tumors?

Earlier studies have used [18F] Fluoroethyl-L-tyrosine PET/MRI to detect pituitary tumors. The available research does not provide detailed safety information for this specific treatment. However, as a Phase 1 trial, the study primarily focuses on assessing the treatment's safety and side effects in people. Phase 1 trials typically evaluate how well patients tolerate a new treatment. Although extensive safety data for [18F] Fluoroethyl-L-tyrosine is not yet available, ongoing research aims to ensure its safety for people. Researchers will closely monitor participants in this trial for any adverse reactions to the treatment.12345

Why are researchers excited about this trial?

Researchers are excited about the use of [18F] Fluoroethyl-L-tyrosine (FET) in PET/MRI for pituitary tumors because it offers a novel imaging technique that could improve the accuracy of tumor detection. Unlike standard imaging techniques like conventional MRI, FET-PET/MRI leverages a new active ingredient, FET, which targets amino acid transport in tumors, potentially providing clearer images of tumor activity. This method is particularly promising for patients with conditions like Cushing's Disease, Acromegaly, or hyperprolactinemia, where tumors might be difficult to detect with traditional methods. By offering a more precise way to visualize tumors, FET-PET/MRI could lead to better surgical outcomes and more personalized treatment plans.

What evidence suggests that FET-PET/MRI is effective for detecting pituitary tumors?

Research shows that using a special scan called [18F] Fluoroethyl-L-tyrosine PET (FET-PET) with an MRI can detect hidden pituitary tumors that regular MRI scans might miss. This method has successfully identified small, active pituitary tumors in conditions like Cushing's disease and acromegaly. In this trial, participants will undergo the FET-PET/MRI scan to confirm the presence of these tumors, which previous studies have shown to improve outcomes for several patients. While primarily used for diagnosis, early evidence suggests it could also help doctors decide on the best treatment for pituitary tumors. This technique might enhance tumor detection and influence surgery and treatment choices, potentially leading to better patient outcomes.23567

Who Is on the Research Team?

NS

Neetu Soni, MBBS, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with certain hormone-related pituitary tumors (Cushing's disease, acromegaly, or high prolactin) that can't be clearly seen on standard MRI. Participants must be able to have surgery if a tumor is found and not be pregnant.

Inclusion Criteria

I am a woman who can become pregnant and have a recent negative pregnancy test.
I am 18 to 75 years old and have been diagnosed with CD, Acromegaly, or tumor hyperprolactinemia.
* Clinical DCE-MRI protocol that is negative or equivocal for identifiable tumor.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo FET-PET/MRI to detect MRI-occult primary or residual/recurrent functional pituitary adenomas

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • [18F] Fluoroethyl-L-tyrosine

Trial Overview

The study tests whether an advanced imaging scan called FET-PET/MRI can better detect small pituitary tumors that regular MRI misses. The goal is to see if this helps guide treatment or surgical decisions.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: FET-PET/MRIExperimental 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

Use of [18F] Fluoroethyl-L-tyrosine PET/MRI for Identifying ...

The purpose of this research is to evaluate the diagnostic role and clinical efficacy of investigational FET-PET/MRI in detecting MRI-occult ...

2.

pubmed.ncbi.nlm.nih.gov

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

fluoro-ethyl-L-tyrosine PET ([18F]FET-PET) correlated with ...

Purpose: To assess the clinical value of [18F]fluoroethyl-L-tyrosine PET ([18F]FET-PET) correlated with MRI in patients with functioning ...

OC03 - [18F] Fluorethyltyrosine positron emission tomography ...

Histopathological confirmation and biochemical remission was achieved in 9 of these cases. Conclusion(s). [18F]FET PET is effective in ...

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

To assess the clinical value of [18F]fluoroethyl-L-tyrosine PET ([18F]FET-PET) correlated with MRI in patients with functioning pituitary ...

Use of [18F]FET PET-MRI to Improve Detection of Pituitary ...

This has a major impact on the therapeutic approach, short and long-term remission rates, and other outcomes. Hybrid Positron-emission ...

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

F-FET has not yet proven clinical efficacy in pituitary adenomas except for a retrospective case series of FET-PET/MRICR in Cushing's disease.

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

The aim of this prospective diagnostic study is to compare the diagnostic accuracy of [18F]FET-PET-MRI and IPSS in differentiating CD from ectopic CS in ...