124I-cG250 Imaging for Kidney Cancer Response Detection

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: VEGF receptor TKI

Disqualifiers: Pregnancy, Unstable cardiac disease, others

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

Compensation: Varies

Number of Visits: 24

Duration: 6 cycles

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new scan, called 124I-cG250 PET/CT, to determine if it can detect kidney cancer treatment responses earlier than regular CT scans. It targets patients with advanced kidney cancer who are starting treatment with drugs like sunitinib or pazopanib. The scan uses a special antibody that binds to cancer cells, making them visible with a radioactive tracer. This trial may suit those diagnosed with clear cell renal cell carcinoma who are about to begin treatment with specific cancer therapies. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance early detection of treatment responses.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you have not taken a VEGF receptor TKI (a type of cancer drug) recently, within a time period equivalent to 5 half-lives of the drug. It's best to discuss your current medications with the study team.

What prior data suggests that this imaging technique is safe for detecting kidney cancer response?

Research shows that 124I-cG250 is a special antibody combined with a radioactive material called Iodine-124, used in scans to detect kidney cancer. Although specific safety information for 124I-cG250 is unavailable, a similar compound, 131I-cG250, has been used in kidney cancer patients, providing some insight into how these treatments might work.

In this study, 124I-cG250 is used with PET/CT scans to determine if it can detect cancer changes sooner than regular scans when patients receive drugs like sunitinib or pazopanib. This new imaging method aims to reveal cancer activity more quickly.

Without direct safety data for 124I-cG250, determining its tolerance is challenging. However, since the trial focuses on monitoring and imaging rather than direct treatment, it likely has fewer side effects than treatments like chemotherapy. Discussing potential risks and benefits with a healthcare provider is important for understanding your specific situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 124I-cG250 because it offers a new way to detect how well kidney cancer treatments are working. Unlike standard imaging methods like CT scans, 124I-cG250 uses a special PET/CT imaging process that involves a radioactive tracer specifically designed to target clear cell renal cell carcinoma (ccRCC). This could potentially provide more accurate and earlier insights into whether treatments like sunitinib or pazopanib are effectively attacking the cancer. This method could help doctors make quicker and more informed decisions about a patient's treatment plan.

What evidence suggests that this imaging technique is effective for detecting kidney cancer response?

In this trial, participants will undergo a special imaging method called 124I-cG250 PET/CT. Research has shown that this method can detect clear-cell renal cell carcinoma (ccRCC) with about 86% accuracy. The method uses an antibody, cG250, which attaches to cancer cells and is marked with a radioactive signal, Iodine-124, causing the cancer cells to light up on a PET scan. This enables doctors to assess treatment effectiveness sooner. Studies suggest this method might reveal treatment effects faster than regular CT scans, which could take months. Detecting changes early could be crucial in managing kidney cancer more effectively. ^{1 6 7 8 9}

Who Is on the Research Team?

Darren Feldman, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults with advanced/metastatic clear cell renal carcinoma, who are about to start VEGF receptor TKI therapy like sunitinib or pazopanib. They should be in good enough health for the trial (ECOG ≤2), have manageable side effects from previous treatments, and meet specific blood test criteria. Pregnant women, those with certain medical conditions or a history of severe reactions to similar drugs can't participate.

Inclusion Criteria

I am scheduled for treatment with specific cancer drugs targeting blood vessel growth.

I can do most of my daily activities on my own.

My side effects from previous cancer treatments are mild or gone.

Exclusion Criteria

You cannot have a CT scan with a special dye.

You have been treated with medications containing certain types of proteins in the past.

I am not pregnant or breast-feeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sunitinib or pazopanib and are monitored using 124I-cG250-PET/CT for early detection of response

6 cycles

PET/CT scans at day 24-29 and day 39-42

Follow-up

Participants are monitored for progression-free survival and radiation dosimetry

9 months

Long-term follow-up

Participants are monitored for detection of metastatic lesions and radiation dosimetry

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 124IcG250

Trial Overview The study is testing if a new PET/CT scan using the radioactive tracer 124I-cG250 can detect early responses to kidney cancer treatment better than regular CT scans. This involves an antibody that targets cancer cells and shows up on scans, potentially identifying treatment effectiveness sooner.

How Is the Trial Designed?

Group I: 124IcG250 Experimental Treatment 1 Intervention

This is a pilot study of 124I-cG250-PET/CT in 25 evaluable patients with advanced and/or metastatic clear cell renal cell carcinoma (ccRCC) who are scheduled to begin treatment with sunitinib or pazopanib. 124I-cG250-PET/CT will be assessed for its ability to predict response in comparison to standard CT scan of the chest, abdomen, and pelvis.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Telix Pharmaceutical

Collaborator

Trials

2

Recruited

30+

Published Research Related to This Trial

In a study of 18 patients with renal cell carcinoma (RCC), [68 Ga]Ga-FAPI-04 PET/CT demonstrated significantly higher tumor-to-background ratios (TBR) compared to [18F]F-FDG PET/CT, indicating better imaging performance for detecting lesions (median TBR of 5.6 vs. 2.1, p < 0.001).

The results suggest that [68 Ga]Ga-FAPI-04 PET/CT could serve as a complementary imaging tool for RCC, potentially aiding in prognosis and theranostic applications, as 39% of patients had lesions with high SUVmax values (≥10).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of [68&#160;Ga]Ga-FAPI-04 PET/CT in renal cell carcinoma: a preliminary study. Civan, C., Kuyumcu, S., Has Simsek, D., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01582204

Study Details | Evaluate The Utility Of 124I-cG250 for The Early ... Evaluate The Utility Of 124I-cG250 for The Early Detection Of Response to Therapy In Patients With Metastatic Renal Cell Carcinoma ... kidney cancer with CT scans ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3126050/

PET/CT imaging of clear cell renal cell carcinoma with 124I ... In this paper we describe the development of a radiolabeled antibody specific to ccRCC (124I-cG250) and its potential to help urologists manage each of these ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2016-00988

124I-cG250 PET/CT in Early Detection of Response to ... Diagnostic procedures, such as 124I-cG250 PET/CT, may detect the spread of tumor cells to other places in the body and help determine response to treatment.

4. ajronline.org ajronline.org/doi/10.2214/AJR.14.12490

PET/CT With 124I-cG250: Great Potential and Some Open ... OBJECTIVE. A novel PET radiotracer, 124I-cG250, is currently under clinical investigation to distinguish clear cell renal cell carcinoma ...

5. withpower.com withpower.com/trial/phase-kidney-neoplasms-3-2012-1497b

124I-cG250 Imaging for Kidney Cancer Response Detection The treatment 124I-cG250, used in PET imaging, has been shown to accurately identify clear-cell renal cell carcinoma (ccRCC) with high sensitivity (86%) and ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S147020450770044X

Preoperative characterisation of clear-cell renal carcinoma ... PET with 124 I-cG250 can identify accurately clear-cell renal carcinoma; a negative scan is highly predictive of a less aggressive phenotype.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5795663/

Results From the REDECT Trial - PubMed Central - NIH A clinical study to characterize renal masses with positron emission tomography/computed tomography (PET/CT) was undertaken.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT00199888?term=AREA%5BBasicSearch%5D(rencarex%20renal%20cell%20carcinoma)&rank=1

Safety Study With the Antibody, cG250, and Isotope, 124- ... A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2295251/

Antibody therapy in renal cell carcinoma - PMC Other endpoints of the study included overall survival, time to progression, time to treatment failure, overall response rate, and safety profile. The addition ...