97 Participants Needed

PET/MR Imaging for Kidney Tumors

UR
Overseen ByUTSW Radiology Clinical Research Office
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Texas Southwestern Medical Center
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 if a special imaging technique called PET/MR can better identify different types of kidney tumors. Many kidney tumors discovered incidentally during scans for other issues are not cancerous, yet they often lead to unnecessary treatments. The trial seeks to determine if PET/MR can distinguish between aggressive tumors that might spread and those that are harmless or slow-growing. Individuals who might be suitable for this trial have a suspicious kidney mass and are already scheduled for an MRI. Participants will receive a PET/MR scan and might be contacted for follow-ups to monitor health changes over time.

As a Phase 2 trial, this research focuses on measuring how well PET/MR works in an initial, smaller group of people, offering participants a chance to contribute to advancements in kidney tumor diagnosis.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you can continue them, but it's best to confirm with the study team.

What prior data suggests that this PET/MR technique is safe for assessing kidney tumors?

Research has shown that Fludeoxyglucose (FDG) F 18 has been tested in many patients and is generally well-tolerated. In studies involving 374 people, the treatment did not cause significant side effects. The main issue reported was mild irritation at the injection site, which is rare. FDG, a type of radioactive sugar, is used in imaging tests to help find tumors. The FDA has already approved it for other uses, indicating its safety for humans. Overall, evidence suggests that FDG is safe and causes few problems when administered to patients.12345

Why are researchers excited about this trial?

Researchers are excited about using PET/MRI for characterizing renal masses because it combines the strengths of two powerful imaging techniques. Unlike standard imaging options, such as CT or ultrasound, PET/MRI offers detailed anatomical and metabolic information in one go. This means it can more accurately distinguish between benign and malignant tumors, potentially reducing the need for invasive biopsies. The hope is that this method will lead to more precise diagnoses and better treatment planning for patients with renal masses.

What evidence suggests that this PET/MR technique is effective for distinguishing kidney tumors?

Studies have shown that FDG PET scans can accurately differentiate between types of kidney masses. In one study, FDG-PET correctly identified 23 out of 27 kidney tumors as either non-cancerous or cancerous. Another study found that FDG PET/CT scans effectively distinguish cancerous kidney masses from non-cancerous ones by analyzing their energy usage. This trial will observe patients diagnosed with incidental solid renal masses using FDG PET/MR, potentially helping doctors determine if a kidney mass is dangerous. This improved imaging technique might reduce unnecessary surgeries for non-cancerous or less aggressive kidney masses.678910

Who Is on the Research Team?

IP

Ivan Pedrosa, MD, PhD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Your renal mass size is between 2 and 7 centimetres.
You have a solid renal mass, comprising over 25% of the total volume.
You possess the discernment and are ready to sign a written declaration of consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Imaging and Data Collection

Participants undergo a PET/MR scan to assess kidney tumors, including administration of FDG and furosemide

1 day
1 visit (in-person, ~2.5 hours)

Follow-up

Participants are monitored for health updates and changes in diagnosis through periodic phone calls

Up to 2 years
Phone calls every 6-12 months

What Are the Treatments Tested in This Trial?

Interventions

  • 2-Deoxy-2-[18F]fluoroglucose

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Patient diagnosed with incidental solid renal massExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Radiological Society of North America

Collaborator

Trials
27
Recruited
1,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/16307216/

2-Deoxy-2-[F-18]fluoro-D-glucose-positron emission ...

Results: Of the 28 solid renal masses, 10 were primary (nine malignant, one benign) and 18 were metastatic renal tumors. FDG-PET accurately depicted 23 of 27 ( ...

Utility of Fluorine18 Fluoro-2-deoxy-D-glucose Positron ...

F18-FDG PET/CT can efficiently characterize solid renal mass lesion as benign and malignant using metabolic parameters such as max.SUV and RI.

FDG PET characterization of renal masses: Preliminary ...

This study was undertaken to evaluate the potential efficacy of fluorine-18 2-fluoro-2-deoxy-d-glucose positron emission tomography (FDG PET) to detect renal ...

The Place of FDG PET/CT in Renal Cell Carcinoma

18F-fluoro-2-deoxy-2-d-glucose (FDG) PET seems useful for postoperative surveillance in patients with RCC. It can detect recurrence in the surgical site.

A prospective diagnostic accuracy study of F-18 ...

The results of previous studies made to assess the efficacy of F-18 FDG PET in the evaluation of renal masses are summarized in Table 2. Summary of previous ...

Fludeoxyglucose F 18 Injection - accessdata.fda.gov

Fludeoxyglucose F 18 Injection is provided as a ready to use isotonic, sterile, pyrogen free, clear, colorless citrate buffered solution.

SAFETY DATA SHEET Potential Health Effects

No adverse effect expected, but may cause mechanical irritation. COMPONENTS. CONCENTRATION. CAS NO. 2-Fluoro-2-deoxy-D-glucose. <0.001%.

fludeoxyglucose f-18 injection injection - DailyMed - NIH

It is administered by intravenous injection. The active ingredient 2-deoxy-2-[ 18 ... The [ 18F]FDG safety data base was evaluated for 374 patients. Of these, 245 ...

Fludeoxyglucose F 18 Injection (FDG): Side Effects, Uses, ...

The [18F]FDG safety data base was evaluated for 374 patients. Of ... Estimated Absorbed Radiation Doses after intravenous administration of 2-deoxy-2-[18F ...

Fludeoxyglucose (18F): Uses, Interactions, Mechanism of ...

[18F]-FDG-6-phosphate presumably is metabolized to 2-deoxy-2-[18F] fluoro-6 ... View sample adverse effects data in our new Data Library! See the data.