PET/CT Imaging for Kidney Cancer

Overseen By Nicole Phillips

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Western University

Disqualifiers: Pregnant, Under 18, Prior malignancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique called PET/CT with a special tracer, [18F] PSMA-1007, to better detect the spread of kidney cancer. The goal is to determine if this method can identify cancer that other scans might miss, potentially altering treatment approaches. Individuals with kidney cancer that includes a clear cell component and who have already undergone standard scans might be suitable for this study. As an Early Phase 1 trial, the study aims to understand how this new imaging technique functions in people, offering participants the opportunity to be among the first to benefit from potentially groundbreaking diagnostic advancements.

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 prior data suggests that this imaging technique is safe for kidney cancer patients?

Research has shown that [18F] PSMA-1007 PET/CT is under study for its potential to image cancer. One study compared it to another imaging method and found it similarly effective in detecting cancer spread, suggesting it may be useful in identifying cancer's spread in the body.

However, specific safety information from these studies remains limited. As this trial is in its early stages, the primary focus is on assessing the treatment's safety. Early trials typically involve small groups to evaluate how well participants tolerate the treatment. While some information about how [18F] PSMA-1007 functions is available, further research is necessary to understand potential side effects. Participants should be aware that not all side effects may be known at this stage. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F] PSMA-1007 PET/CT for kidney cancer because it offers a novel approach to imaging compared to traditional methods like CT or MRI scans. This treatment uses a specific radioactive tracer, [18F] PSMA-1007, which targets the prostate-specific membrane antigen (PSMA) often found in higher levels in certain cancer cells. This targeting allows for more precise imaging of cancerous tissues, potentially leading to better diagnosis and treatment planning. Unlike standard imaging techniques, which may struggle to distinguish between cancerous and non-cancerous tissues, [18F] PSMA-1007 PET/CT offers the promise of greater accuracy and clarity, paving the way for improved patient outcomes.

What evidence suggests that [18F] PSMA-1007 PET/CT is effective for staging kidney cancer?

Research has shown that [18F] PSMA-1007 PET/CT scans outperform traditional methods in detecting cancer spread. This scan excels at identifying metastatic kidney cancer compared to standard scans like CT or MRI. Studies have found that [18F] PSMA-1007 PET/CT can reveal hidden cancer spread, crucial for selecting the best treatment. It also more accurately determines the stage of prostate cancer, suggesting similar success for kidney cancer. Early evidence indicates that using [18F] PSMA-1007 PET/CT could help doctors make better treatment decisions by providing a clearer view of cancer spread. Participants in this trial will undergo the [18F] PSMA-1007 PET/CT scan to assess its effectiveness in detecting kidney cancer spread. ^{1 6 7 8 9}

Who Is on the Research Team?

Melissa Huynh, MD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

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 have been diagnosed with advanced kidney cancer.

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

Exclusion Criteria

Pregnant or breastfeeding

I cannot lie flat for 30 minutes.

My cancer does not have clear cell features.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• [18F] PSMA-1007 PET/CT

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1.

jnm.snmjournals.org

jnm.snmjournals.org/content/early/2025/10/23/jnumed.125.269818

Efficacy of [18F]PSMA-1007 PET/CT in Primary Staging of ...

In terms of sensitivity for M staging on a patient level, [18F]PSMA-1007 PET/CT outperformed all other tested conventional imaging modalities.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10854516/

Head-to-Head Comparison of [18F]PSMA-1007 and [18F]FDG ...

The study involves 10 TNBC patients, revealing comparable uptake of [ 18 F]PSMA-1007 and [ 18 F]FDG in primary and metastatic lesions.

3.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.455

18F-PSMA-1007 PET/CT for response assessment in ...

In this research, our aim was to compare response assessments using PSMA PET versus CT scans in a larger cohort of mRCC patients undergoing ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38949926/

Fluorine-18 Prostate-Specific Membrane Antigen-1007 ...

In this phase 2 prospective validating paired cohort study, 18F-PSMA-1007 PET/CT was superior to MRI for the locoregional staging of prostate cancer.

5.

jnm.snmjournals.org

jnm.snmjournals.org/content/66/supplement_1/251575

Comparison of [¹⁸F]PSMA-1007, [¹⁸F]DCFPyL, and [⁶⁸Ga ...

Introduction: PSMA PET/CT imaging has transformed prostate cancer detection, staging, and restaging. Key [¹⁸F]-based tracers ([¹⁸F]PSMA-1007 ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0969805121005345

Recent advancements in 18F-labeled PSMA targeting PET ...

In this review, we will give an overview of these recent advancements of 18 F-labeled PSMA PET radioligands.

7.

jamanetwork.com

jamanetwork.com/journals/jamaoncology/fullarticle/2820678

Fluorine-18 PSMA-1007 PET/CT vs Multiparametric MRI for ...

18 F-PSMA-1007 PET/CT correctly identified the final pathological tumor stage in 61 men (45%) compared to 38 men (28%) with multiparametric MRI.

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06428708

[18F] PSMA-1007 PET/CT in Metastatic Clear Cell Renal ...

This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear ...

9.

link.springer.com

link.springer.com/article/10.1007/s00259-022-06089-w

PSMA PET/CT: joint EANM procedure guideline/SNMMI ...

Here we aim to provide updated guidance and standards for the indication, acquisition, and interpretation of PSMA PET/CT for prostate cancer imaging.