← Back to Search

124I-cG250 Imaging for Kidney Cancer Response Detection

N/A

Waitlist Available

Led By Steven Larson, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be planned for treatment with approved treatment doses of a VEGF receptor TKI (e.g., sunitinib, pazopanib, cabozantinib, axitinib, sorafenib, lenvatinib)

ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2

Must not have

Women who are pregnant or breast-feeding

Uncontrolled or unstable hyperthyroidism or Grave's Disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether 124I-cG250 PET/CT can show if sunitinib or pazopanib is working against kidney cancer sooner than a regular CT scan.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include allergic reactions due to the antibody used or exposure to radiation from the tracer Iodine-124. There could also be risks associated with contrast agents used during CT scans such as kidney damage or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

My cancer is advanced or has spread, and it's confirmed to be clear cell carcinoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant or breast-feeding.

Select...

My thyroid condition is not under control.

Select...

I cannot take IOSATTM due to health reasons listed on its package.

Select...

I haven't had a stroke, mini-stroke, or uncontrolled seizures in the last year.

Select...

I do not have active hepatitis B/C or HIV.

Select...

I have not taken any VEGF receptor inhibitors recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

accuracy of predicting

Secondary study objectives

Detection of metastatic lesions

To evaluate the radiation dosimetry of 124I-cG250.

progression-free survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 124IcG250Experimental Treatment1 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.

0 / 9Eligibility criteria met