PET/CT Imaging for Kidney Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Melissa Huynh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Western University

Disqualifiers: Pregnant, Under 18, Prior malignancy, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment [18F] PSMA-1007 PET/CT for kidney cancer?

Research shows that [18F] PSMA-1007 PET/CT can effectively highlight kidney tumors and lung nodules, providing valuable information about the type and stage of kidney cancer. This imaging method is promising for understanding and planning treatment for kidney cancer, similar to its use in prostate cancer. ^{1 2 3 4 5}

Is 18F-PSMA-1007 PET/CT safe for humans?

Research on 18F-PSMA-1007 PET/CT, primarily used for prostate cancer imaging, indicates it is generally safe for humans. It has been tested in human volunteers and patients, showing good tumor detection and fast clearance from the body without significant safety concerns. ^{1 3 6 7 8}

How does PET/CT imaging differ from other treatments for kidney cancer?

PET/CT imaging for kidney cancer is unique because it uses a special tracer that targets prostate-specific membrane antigen (PSMA), which is also present in the blood vessels of kidney tumors. This imaging method can provide detailed information about the tumor's type and stage, which is not typically available with standard imaging techniques. ^{1 2 3 4 9}

Research Team

Melissa Huynh, MD

Principal Investigator

Western University

Eligibility Criteria

This trial is for individuals with metastatic clear cell renal cell carcinoma. It's designed to see if a new type of PET/CT scan can find hidden cancer spread better than current methods.

Inclusion Criteria

Exception: Unenhanced CT of the chest is acceptable

I've had recent scans of my chest, abdomen, and pelvis with contrast.

I have been diagnosed with advanced kidney cancer.

Exclusion Criteria

Pregnant or breastfeeding

I cannot lie flat for 30 minutes.

My cancer does not have clear cell features.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Baseline Assessment

Participants undergo baseline conventional imaging and [18F] PSMA-1007 PET/CT to identify metastatic lesions

5 weeks

1 visit (in-person)

Follow-up

Participants are monitored for changes in management based on imaging results

4 weeks

Treatment Details

Interventions

• [18F] PSMA-1007 PET/CT (Procedure)

Trial Overview [18F] PSMA-1007 PET/CT imaging is being tested to improve the detection of metastases in kidney cancer, which could influence treatment decisions between surgery, radiation, or systemic therapy.

Participant Groups

Group I: [18F] PSMA-1007 PET/CT Experimental Treatment 1 Intervention

All patients enrolled undergo a \[18F\] PSMA-1007 PET/CT

Who Is Running the Clinical Trial?

Western University

Lead Sponsor

Trials

31

Recruited

129,000+

Findings from Research

F-PSMA 1007 PET/CT demonstrated intense tracer concentration in both the primary renal tumor and lung nodules in a 60-year-old man suspected of having renal cell carcinoma, suggesting its effectiveness in identifying tumor presence.

This imaging technique may offer valuable preoperative insights into tumor characteristics, staging, and potential treatment options, indicating its utility in evaluating suspected renal cell carcinoma compared to traditional F-FDG PET/CT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-PSMA 1007 in Suspected Renal Cell Carcinoma. Marafi, F., Sasikumar, A., Al-Terki, A., et al.[2021]

In a study of 37 patients with metastatic renal cell carcinoma (RCC), 68Ga-PSMA-11 PET/CT was found to be more effective than contrast-enhanced computed tomography (CECT) and 18F-FDG PET/CT in detecting bone lesions and assessing tumor burden, which is crucial for patient management.

The use of 68Ga-PSMA-11 PET/CT not only improved lesion detection rates but also provided prognostic information that could impact patient survival, particularly in those with clear cell RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential role of 68Ga-PSMA PET/CT in metastatic renal cell cancer: A prospective study. Aggarwal, P., Singh, H., Das, CK., et al.[2023]

In a study involving 8 patients with metastatic non-clear cell renal cell carcinoma (RCC), only 13.7% of identified metastatic lesions showed definitive uptake of the PSMA-targeted radiotracer [18F]DCFPyL, indicating limited efficacy for this imaging method in detecting non-clear cell RCC.

The findings suggest that PSMA-based PET imaging is not suitable for non-clear cell RCC subtypes, as the majority of lesions (67.1%) did not show any significant radiotracer uptake, contrasting with its effectiveness in clear cell RCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inconsistent Detection of Sites of Metastatic Non-Clear Cell Renal Cell Carcinoma with PSMA-Targeted [18F]DCFPyL PET/CT. Yin, Y., Campbell, SP., Markowski, MC., et al.[2022]

PSMA PET imaging, primarily used for prostate cancer, shows promise as a diagnostic tool for renal cell carcinoma (RCC) due to the high expression of PSMA on the microvasculature of various solid tumors.

This review highlights the potential of PSMA PET/CT for staging and monitoring RCC, suggesting it could enhance the accuracy of imaging in this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA PET/CT in Renal Cell Carcinoma: An Overview of Current Literature. Muselaers, S., Erdem, S., Bertolo, R., et al.[2022]

F-18-PSMA-1007-PET is effective for staging prostate cancer, particularly in identifying seminal vesicle invasion, outperforming mpMRI with a correct staging rate of 90% compared to 76%.

The study suggests that combining F-18-PSMA-1007-PET with mpMRI could enhance the overall accuracy of prostate cancer staging, as mpMRI was better at detecting extracapsular extension (90% vs. 57%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating F-18-PSMA-1007-PET in primary prostate cancer and comparing it to multi-parametric MRI and histopathology. Privé, BM., Israël, B., Schilham, MGM., et al.[2022]

PSMA-based PET-CT imaging using fluorine-18 PSMA-1007 is effective for staging high-risk prostate cancer and locating recurrent disease, offering advantages like hepatobiliary excretion and a longer half-life compared to gallium tracers.

Despite its benefits, there are still some ambiguities and potential pitfalls in interpreting the results of PSMA-1007 imaging, which need to be considered in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluorine-18 labelled prostate-specific membrane antigen (PSMA)-1007 positron-emission tomography-computed tomography: normal patterns, pearls, and pitfalls. Foley, RW., Redman, SL., Graham, RN., et al.[2021]

The new PET tracer 18F-PSMA-1007 shows promising results for detecting prostate cancer, with an effective dose similar to other PSMA-targeting agents and significantly reduced urinary clearance, allowing for better imaging of the prostate.

In a study involving 10 patients with high-risk prostate cancer, 18F-PSMA-1007 successfully detected 18 out of 19 lymph node metastases, demonstrating its efficacy in identifying small tumors and validating its diagnostic capabilities with histopathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. Giesel, FL., Hadaschik, B., Cardinale, J., et al.[2023]

The novel 18F-labelled PSMA-1007 ligand shows a significant increase in uptake in prostate cancer lesions over time, with maximum standardized uptake (SUVmax) rising from 10.98 at 60 minutes to 15.51 at 120 minutes post-injection, indicating improved detection capabilities.

Low accumulation of the tracer in the urinary bladder enhances the visibility of nearby prostate cancer lesions, although increased uptake in the liver may reduce the sensitivity for detecting liver metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-PSMA-1007 PET/CT at 60 and 120 minutes in patients with prostate cancer: biodistribution, tumour detection and activity kinetics. Rahbar, K., Afshar-Oromieh, A., Bögemann, M., et al.[2019]

68Ga-PSMA PET/CT is an effective imaging technique not only for prostate cancer but also shows potential in identifying PSMA expression in the neovasculature of other cancers, such as renal cell carcinoma.

The study presents two cases of renal cell carcinoma with distinct PSMA expression characteristics, highlighting the variability in PSMA expression among different histopathological subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-PSMA Uptake Patterns of Clear Cell Renal Carcinoma Across Different Histopathological Subtypes. Oflas, M., Ozluk, Y., Sanli, O., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

18F-PSMA 1007 in Suspected Renal Cell Carcinoma. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

Potential role of 68Ga-PSMA PET/CT in metastatic renal cell cancer: A prospective study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Inconsistent Detection of Sites of Metastatic Non-Clear Cell Renal Cell Carcinoma with PSMA-Targeted [18F]DCFPyL PET/CT. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

PSMA PET/CT in Renal Cell Carcinoma: An Overview of Current Literature. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating F-18-PSMA-1007-PET in primary prostate cancer and comparing it to multi-parametric MRI and histopathology. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Fluorine-18 labelled prostate-specific membrane antigen (PSMA)-1007 positron-emission tomography-computed tomography: normal patterns, pearls, and pitfalls. [2021]

7. Germany pubmed.ncbi.nlm.nih.gov

F-18 labelled PSMA-1007: biodistribution, radiation dosimetry and histopathological validation of tumor lesions in prostate cancer patients. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

18F-PSMA-1007 PET/CT at 60 and 120 minutes in patients with prostate cancer: biodistribution, tumour detection and activity kinetics. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

68Ga-PSMA Uptake Patterns of Clear Cell Renal Carcinoma Across Different Histopathological Subtypes. [2023]