RECRUITING

An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer

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Conditions

Clear Cell Renal Cell CarcinomaSarcomatoid Renal Cell CarcinomaStage II Renal Cell CancerStage III Renal Cell CancerStage IV Renal Cell CancerRenal

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)/computed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET/CT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 89Zr-DFO-GmAb PET/CT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.

Official Title

89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery

Quick Facts

Study Start:2024-08-06
Study Completion:2030-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06447103

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18
  2. * Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on partial/radical nephrectomy/metastasectomy)
  3. * For tumors with extensive sarcomatoid features, if there is evidence of areas of clear cell and high CAIX expression throughout the tumor on immunohistochemistry, they will be allowed on study
  4. * Subjects must have undergone definitive treatment of their primary tumor (partial/radical nephrectomy) +/- resection of metastatic disease to no evidence of disease (NED) with a prior nephrectomy \< 2 years)
  5. * Surgery must have been performed between 4-16 weeks at the time of planned imaging
  6. * Subjects are considered to have a high risk of recurrence based on the following criteria:
  7. * Intermediate-high risk ccRCC:
  8. * pathologic tumor stage 2 (pT2), grade 4, or sarcomatoid, N0, M0
  9. * pathologic tumor stage 3 (pT3), any grade, N0, M0
  10. * High risk ccRCC:
  11. * pathologic tumor stage 4 (pT4), any grade, N0, M0
  12. * pT any stage, any grade, number of positive nodes (pN+), M0
  13. * M1 now NED: pathologically-confirmed ccRCC, undergoing a resection of a solitary, isolated soft tissue metastasis within two years from initial nephrectomy
  14. * Negative serum pregnancy tests in female patients of childbearing potential. (Women of child bearing potential \[WOCBP\] require a negative pregnancy test within 24 hours (urine) prior to receiving investigational product)
  15. * Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-DFO-GmAb administration
  16. * Individual must be able to remain still and lie flat for duration of the diagnostic imaging procedure (less than 1 hour)
  1. * Inability to provide written informed consent
  2. * Any evidence of residual disease or known metastasis at the time of planned 89Zr-DFO-GmAb administration
  3. * Prior post-operative imaging for confirmation of disease status
  4. * An untreated non-renal malignancy with the following exceptions:
  5. * Low risk prostate cancer on active surveillance (National Comprehensive Cancer Network \[NCCN\] very low/low risk)
  6. * Non-melanoma skin cancer
  7. * Any prior treated malignancy meeting the following characteristics:
  8. * Treated stage I or II cancer from which the patient is currently in complete remission
  9. * A stage III cancer from which the patient is progressing or has been disease-free for and has required active treatment (e.g. adjuvant or maintenance therapy) within the past 3 years prior to enrollment
  10. * A hematologic malignancy from which the patient is currently in complete remission
  11. * Contraindication to the use of iodinated contrast-enhanced CT agents, based on:
  12. * Severe allergy (for which pre-medication cannot limit adverse reactions) or
  13. * Estimated glomerular filtration rate (GFR) ≤ 30 ml/min/1.73m\^2
  14. * Prior use of systemic therapy treatment for kidney cancer (PD-1, PD-L1, tyrosine kinase or TOR inhibitor) or radiotherapy within 4 weeks of enrollment
  15. * Exposure to experimental diagnostic or therapeutic drug within 14 days from date of planned administration
  16. * Women who are pregnant or breastfeeding
  17. * Known hypersensitivity to girentuximab
  18. * Known inability to remain still and lie flat imaging procedure (about 30 minutes)

Contacts and Locations

Principal Investigator

Brian Shuch
PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center

Study Locations (Sites)

UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: Jonsson Comprehensive Cancer Center

  • Brian Shuch, PRINCIPAL_INVESTIGATOR, UCLA / Jonsson Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-06
Study Completion Date2030-12-01

Study Record Updates

Study Start Date2024-08-06
Study Completion Date2030-12-01

Terms related to this study

Keywords Provided by Researchers

  • Renal

Additional Relevant MeSH Terms

  • Clear Cell Renal Cell Carcinoma
  • Sarcomatoid Renal Cell Carcinoma
  • Stage II Renal Cell Cancer
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer