New PET scan could reveal kidney cancer drug success in weeks, not months

NCT ID NCT01582204

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This study tests whether a new type of PET scan using a radioactive antibody called 124I-cG250 can detect if kidney cancer is responding to targeted therapy (sunitinib or pazopanib) earlier than standard CT scans. The antibody attaches to a protein found on kidney cancer cells, making them visible on the scan. Researchers hope this approach can predict treatment success within the first month, instead of waiting several months for tumor shrinkage on a CT scan. The trial involves 17 adults with advanced clear cell kidney cancer who are about to start standard targeted therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
124I-cG250
What this could lead to
If successful, this imaging method could allow doctors to see whether a kidney cancer drug is working weeks earlier than standard scans, helping tailor treatment faster.
What could go wrong
This is a small pilot study with only 17 participants, so results may not apply broadly. The scan involves a radioactive tracer, and its accuracy compared to standard methods is still unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

17 people

The number who actually took part.

Start date

Apr 2012

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically confirmed clear cell carcinoma (conventional) with advanced and/or metastatic disease. * Radiographic evidence of unidimensionally measurable disease. Lesions will be considered measurable or non- measurable as per definitions provided in RECIST version 1.1 * Subjects must be planned for treatment with approved treatment doses of a VEGF receptor TKI (e.g., sunitinib, pazopanib, cabozantinib, axitinib, sorafenib, lenvatinib). * Male or female, 18 years of age or older. * ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2. * Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, or surgical procedure to NCI CTCAE grade ≤2. * The following laboratory results should be within the following limits, within 2 weeks prior to study start: * Absolute neutrophil count (ANC) ≥1.5 x 109/L * Total serum bilirubin \<2.0 mg/dL * Platelets ≥100,000/μL * Serum creatinine ≤2.0 mg/dL * Aspartate aminotransaminase (AST) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets) * Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5.0x in case of liver mets) * Valid written informed consent signed by the patient prior to any study-specific procedures. Exclusion Criteria: * Women who are pregnant or breast-feeding. Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy. A negative pregnancy test is required within 24 hours of administration of radiotracer and study initiation for women of childbearing age and potential. * Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study. * Prior treatment with a VEGF receptor TKI within a time period equivalent to 5 half-lives of the prior TKI (e.g., there should be no substantial amount of TKI remaining in the patient). * Patient is unable to undergo contrast-enhanced CT. * Uncontrolled or unstable hyperthyroidism or Grave's Disease. * Contraindication to IOSATTM intake (see package insert). * Uncontrolled active seizure disorder or history of cerebrovascular accident (CVA) or transient ischemic (TI) attack within the past 12 months. * Unstable cardiac disease, e.g., unstable angina, congestive heart failure or myocardial infarction within the preceding 6 months. * Known active hepatitis B/C or HIV (human immunodeficiency virus) infection. * Prior exposure to murine proteins or chimeric antibodies.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

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