Evidence map›Paper›PMID 23213092›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Positron emission tomography/computed tomography identification of clear cell renal cell carcinoma: results from the REDECT trial.

Chaitanya R Divgi, Robert G Uzzo, Constantine Gatsonis, Roman Bartz, Silke Treutner, Jian Qin Yu, David Chen, Jorge A Carrasquillo, Steven Larson, Paul Bevan and 1 more

Erratum issued Registry-linked trialOpen access · greenAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06750419 (A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab), which is not on this map. Cited by 105 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
105citing papers in PubMed, 3 pooled it
14.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06750419 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

A Confirmatory, Open-label, Single-arm, Multi-centre Study to Evaluate Safety, Tolerability and Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) to Non-invasively Detect Clear Cell Renal Cell Carcinoma (ccRCC) by Positron Emission Tomography/Computed Tomography (PET/CT) Imaging in Chinese Patients With Indeterminate Renal Masses (ZIRCON-CP Study)

TypeinterventionalSponsorTelix Pharmaceuticals (Innovations) Pty LimitedRan2024 to 2026Enrolled82ConditionsClear Cell Renal Cell CarcinomaArms89Zr-TLX250 PET/CT
3 · Its place in the literature

Who cites it

105 citing papers in PubMed, 3 syntheses or guidelines pooled it, 254 citations in OpenAlex.

  1. SNMMI/EANM/ACNM Procedure Standard/Procedure Guideline on the Use of Molecular Imaging for Renal Mass Characterization.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    Guideline
  2. Pooled it
  3. Pooled it
  4. A prospective head-to-head comparison ofEuropean journal of nuclear medicine and molecular imaging · 2026
    Trial
  5. Trial
  6. [European journal of nuclear medicine and molecular imaging · 2026
    Trial
  7. Diagnostic efficacy of [European journal of nuclear medicine and molecular imaging · 2024
    Trial
  8. A Microdosing Study withJournal of nuclear medicine : official publication, Society of Nuclear Medicine · 2021
    Trial
  9. Lesion detection by [European journal of nuclear medicine and molecular imaging · 2019
    Trial
  10. Trial
  11. Trial
  12. Trial
  13. Review
  14. Article
  15. Review
  16. Review
  17. Carbonic Anhydrase Inhibitors in Oncology.Sub-cellular biochemistry · 2026
    Review
  18. SpecificTheranostics · 2026
    Article
  19. Review
  20. Review

45 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

Chaitanya R DivgiColumbia University, New York, NY 10032, USA. crdivgi@columbia.edu
Robert G Uzzo
Constantine Gatsonis
Roman Bartz
Silke Treutner
Jian Qin Yu
David Chen
Jorge A Carrasquillo
Steven Larson
Paul Bevan
Paul Russo
Brown University · USColumbia University Irving Medical Center · USColumbia University · USFox Chase Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeA clinical study to characterize renal masses with positron emission tomography/computed tomography (PET/CT) was undertaken. PATIENTS AND

methodsThis was an open-label multicenter study of iodine-124 ((124)I) -girentuximab PET/CT in patients with renal masses who were scheduled for resection. PET/CT and contrast-enhanced CT (CECT) of the abdomen were performed 2 to 6 days after intravenous (124)I-girentuximab administration and before resection of the renal mass(es). Images were interpreted centrally by three blinded readers for each imaging modality. Tumor histology was determined by a blinded central pathologist. The primary end points-average sensitivity and specificity for clear cell renal cell carcinoma (ccRCC)-were compared between the two modalities. Agreement between and within readers was assessed.

results(124)I-girentuximab was well tolerated. In all, 195 patients had complete data sets (histopathologic diagnosis and PET/CT and CECT results) available. The average sensitivity was 86.2% (95% CI, 75.3% to 97.1%) for PET/CT and 75.5% (95% CI, 62.6% to 88.4%) for CECT (P = .023). The average specificity was 85.9% (95% CI, 69.4% to 99.9%) for PET/CT and 46.8% (95% CI, 18.8% to 74.7%) for CECT (P = .005). Inter-reader agreement was high (κ range, 0.87 to 0.92 for PET/CT; 0.67 to 0.76 for CECT), as was intrareader agreement (range, 87% to 100% for PET/CT; 73.7% to 91.3% for CECT).

conclusionThis study represents (to the best of our knowledge) the first clinical validation of a molecular imaging biomarker for malignancy. (124)I-girentuximab PET/CT can accurately and noninvasively identify ccRCC, with potential utility for designing best management approaches for patients with renal masses.

Indexed as

Antibodies, MonoclonalIodine RadioisotopesRadiopharmaceuticalsCarcinoma, Renal CellCohort StudiesFemaleHumansKidney NeoplasmsMaleMiddle AgedMultimodal ImagingPositron-Emission TomographyTomography, X-Ray Computed124I-girentuximabAntibodies, MonoclonalIodine RadioisotopesRadiopharmaceuticals

Identifiers

PMID23213092
PMCPMC5795663
OpenAlexW2141371088

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.