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

17 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 124I-cG250 for kidney cancer?

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 specificity (87%), providing important preoperative diagnostic information that can lead to personalized therapy. ^{1 2 3 4 5}

Is 124I-cG250 safe for use in humans?

The research does not provide specific safety data for 124I-cG250, but it mentions the use of a similar compound, 131I-cG250, in patients with renal cell carcinoma. This suggests that similar compounds have been used in humans, but specific safety outcomes are not detailed in the provided studies. ^{1 6 7 8 9}

How does the treatment 124I-cG250 differ from other treatments for kidney cancer?

The treatment 124I-cG250 is unique because it uses a special type of imaging called immuno-PET to accurately identify clear-cell renal cell carcinoma (a type of kidney cancer) by targeting a specific protein on cancer cells. This approach allows doctors to distinguish between cancerous and non-cancerous kidney masses more effectively than traditional imaging methods, potentially leading to more personalized treatment plans. ^{1 5 6 10 11}

What is the purpose of this trial?

Usually, doctors monitor kidney cancer with CT scans to measure the size of tumors. Sometimes, even when a drug is working, it can take several months before the effects are seen on a regular CT scan. The purpose of this study is to see if a new kind of scan, called 124I-cG250 PET/CT, can determine response to sunitinib or pazopanib earlier than a regular CT scan. Research has shown that certain proteins in the blood, called antibodies, can attach themselves to cancer cells without binding to normal cells. In this study, an antibody is used called chimeric G250 (cG250) that is attached to a radioactive isotope. The radioactive isotope in this study is Iodine-124 (124I). If cG250 has attached to tumors in the body, 124I shows up on the PET scan.

Research Team

Neeta Pandit-Taskar, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

PET/CT with (124)I-cG250: great potential and some open questions. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

[68Ga]Ga&#8209;LNC1007 PET/CT in the evaluation of renal cell carcinoma: comparison with 2-[18F]FDG/[68Ga]Ga-PSMA PET/CT. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Functional imaging of renal cell carcinoma. [2021]

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

Imaging Advances in the Management of Kidney Cancer. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Potential role of (124)I-girentuximab in the presurgical diagnosis of clear-cell renal cell cancer. [2021]

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

Targeting of renal cell carcinoma with iodine-131-labeled chimeric monoclonal antibody G250. [2022]

7. England pubmed.ncbi.nlm.nih.gov

PET/CT imaging of clear cell renal cell carcinoma with I labeled chimeric antibody. [2021]

8. England pubmed.ncbi.nlm.nih.gov

131 I-cG250 monoclonal antibody immunoscintigraphy versus [18 F]FDG-PET imaging in patients with metastatic renal cell carcinoma: a comparative study. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

The role of [68&#160;Ga]Ga-FAPI-04 PET/CT in renal cell carcinoma: a preliminary study. [2023]

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

Antibody localization in human renal cell carcinoma: a phase I study of monoclonal antibody G250. [2022]

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

In vivo and in vitro characterizations of three 99mTc-labeled monoclonal antibody G250 preparations. [2016]