SPECT/CT for Kidney Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Multiple tumors, Prior biopsy, Non-renal malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for diagnosing kidney tumors using technetium Tc-99m sestamibi SPECT/CT, a type of nuclear medicine scan. The aim is to determine if this technique can assist doctors in making better treatment decisions without invasive procedures. Participants must have received a kidney tumor diagnosis within the last three months, with a tumor size between 1.5 and 5.0 cm and no signs of cancer spreading. This trial may suit those seeking more information to guide their treatment choices. As an unphased trial, it offers participants the chance to contribute to innovative diagnostic research that could enhance future kidney tumor treatment decisions.

Do I have to stop taking my current medications for the trial?

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 technetium Tc-99m sestamibi SPECT/CT is safe for patients with kidney tumors?

Research has shown that technetium Tc-99m sestamibi is generally safe for people. The FDA has approved this substance for imaging various parts of the body, aiding doctors in visualizing internal structures through nuclear medicine. Studies have found that it emits a low level of radiation, comparable to some heart scans.

While safe for most, some individuals might experience mild side effects, such as allergic reactions or watery eyes. In rare instances, it could cause more serious effects like anaphylaxis, a severe allergic reaction.

Overall, technetium Tc-99m sestamibi is considered safe for use in diagnostic tests. However, as with any medical procedure, discussing concerns with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using technetium Tc-99m sestamibi with SPECT/CT for characterizing renal masses because it offers a non-invasive way to evaluate kidney tumors. Unlike traditional methods like biopsies or standard imaging, this approach uses a special radioactive tracer to highlight differences in tissue composition through advanced imaging. This method may provide more accurate information about the nature of the mass, potentially reducing the need for invasive procedures and assisting in more precise treatment planning.

What evidence suggests that technetium Tc-99m sestamibi SPECT/CT is effective for kidney tumors?

Research has shown that a special imaging test called technetium Tc-99m sestamibi SPECT/CT effectively identifies kidney tumors. In one study, 84.5% of patients who underwent this test exhibited at least one "cold" mass, aiding doctors in determining the best treatment. This method can also help avoid unnecessary surgery for non-cancerous tumors, making it cost-effective. SPECT/CT excels at detecting tumors, with a high accuracy rate of 88%. Overall, it enables doctors to make informed decisions about kidney tumors while being less invasive. Participants in this trial will receive technetium Tc-99m sestamibi and undergo SPECT/CT as part of the health service research arm. ^{3 6 7 8 9}

Who Is on the Research Team?

Brian Shuch

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Performance status Eastern Cooperative Oncology Group (ECOG) < 2.

Life expectancy (> 1 year).

New diagnosis of a renal tumor (within past 3 months).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Procedure

Participants receive technetium Tc-99m sestamibi intravenously and undergo SPECT/CT

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in patient management decision and other outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Technetium Tc-99m Sestamibi

How Is the Trial Designed?

Group I: Health service research (MIBI SPECT/CT, questionnaire) Experimental Treatment 4 Interventions

Patients receive technetium Tc-99m sestamibi IV then undergo SPECT/CT.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553148/

Technetium 99m Sestamibi - StatPearls - NCBI Bookshelf - NIH [1] The effective half-life of sestamibi is approximately 5.4 hours, and the physical half-life is approximately 6 hours. The principal photon energy of gamma ...

2. auajournals.org auajournals.org/doi/abs/10.1097/JU.0000000000003557

Clinical Performance of Technetium-99m–Sestamibi ... A total of 71 patients (with 88 masses) underwent technetium-99m–sestamibi imaging with 60 (84.5%) patients having at least 1 “cold” mass on ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32115400/

Cost-effectiveness Analysis of 99mTc-sestamibi SPECT/CT ... 99m Tc-sestamibi SPECT/CT followed by confirmatory biopsy helps avoid surgery for benign SRMs, minimizes untreated malignant SRMs, and is cost effective ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0735109798002915

Significance of rest technetium-99m sestamibi imaging for ... The data of this study indicate that rest Tc-99m sestamibi SPECT can reliably predict myocardial viability as defined by FDG PET or improvement of left ...

5. mirt.tsnmjournals.org mirt.tsnmjournals.org/articles/comparison-of-planar-imaging-using-dual-phase-tc-99m-sestamibi-scintigraphy-and-single-photon-emission-computed-tomographycomputed-tomography-in-hyperparathyroidism/mirt.galenos.2022.60565

Comparison of Planar Imaging Using Dual-phase Tc-99m ... The sensitivity, specificity, and accuracy for SPECT/CT were 88%, 50%, and 75.7%, and 84%, and 50%, and 75.8% for planar imaging, respectively. It was found ...

6. gehealthcare.com gehealthcare.com/-/media/8a21a6c6df9b431a9d79805358313370.pdf?srsltid=AfmBOorSkO2b1v8h7rbSO0HaBb_fPHiVjHinQORsScjvb9KoFya7-cG2

Material Safety Data Sheet Technetium- 99m (Tc-99m) is a gamma emitter with a maximum energy of 0.140 MeV. The physical half-life of Tc-99m is 6.02 hours. Hazard Statements May be ...

7. lantheus.com lantheus.com/assets/technelite-oct20-2015-4-1.pdf

MATERIAL SAFETY DATA SHEET It is a radioactive isotope of. Technetium (Tc-99m). This product can cause: allergic reactions, anaphylaxis, tearing, radioactive material: may cause cancer, ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559013/

Technetium-99m - StatPearls - NCBI Bookshelf Technetium-99m (99mTc) is an FDA-approved radionuclide agent for diagnostic imaging across various human organs, encompassing critical areas such as the brain, ...

9. go.drugbank.com go.drugbank.com/drugs/DB09161

Technetium Tc-99m sestamibi Technetium Tc-99m sestamibi is a radiopharmaceutical diagnostic agent used in nuclear medicine imaging tests to detect coronary artery disease ...