Evidence map›Paper›PMID 38864246›Full record

ArticleJapanese journal of clinical oncology2024

Evaluation of PET/CT imaging with [89Zr]Zr-DFO-girentuximab: a phase 1 clinical study in Japanese patients with renal cell carcinoma (Zirdac-JP).

Noboru Nakaigawa, Hisashi Hasumi, Daisuke Utsunomiya, Keisuke Yoshida, Yoshinobu Ishiwata, Takashi Oka, Colin Hayward, Kazuhide Makiyama

Abstract readClinical Trial, Phase I
In one paragraph

Article in Japanese journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
  2. Review
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  4. Evaluation of [EJNMMI research · 2025
    Article
  5. Review
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  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Noboru NakaigawaDepartment of Urology, Yokohama City University, Yokohama City, Kanagawa 236-0004, Japan.
Hisashi HasumiDepartment of Urology, Yokohama City University, Yokohama City, Kanagawa 236-0004, Japan.
Daisuke UtsunomiyaDepartment of Diagnostic Radiology, Yokohama City University Graduate School of Medicine, Yokohama, Kanagawa 236-0004, Japan.
Keisuke YoshidaDepartment of Diagnostic Radiology, Yokohama City University Graduate School of Medicine, Yokohama, Kanagawa 236-0004, Japan.
Yoshinobu IshiwataDepartment of Diagnostic Radiology, Yokohama City University Graduate School of Medicine, Yokohama, Kanagawa 236-0004, Japan.
Takashi OkaTelix Pharmaceuticals Japan K.K., KRP #4 Building, 93 Chudoji-Awata-machi, Shimogyu-ku, Kyoto-shi, Kyoto, Japan.
Colin HaywardTelix Pharmaceuticals, 55 Flemington Road, North Melbourne, VIC 3051, Australia.ORCID 0009-0007-6423-9669
Kazuhide MakiyamaDepartment of Urology, Yokohama City University, Yokohama City, Kanagawa 236-0004, Japan.

Funding

Telix Pharmaceuticals
6 · The paper itself

Abstract

backgroundPET/CT imaging with Zirconium-89 labeled [89Zr]Zr-DFO-girentuximab, which targets tumor antigen CAIX, may aid in the differentiation and characterization of clear cell renal cell carcinomas (RCC) and other renal and extrarenal lesions, and has been studied in European and American cohorts. We report results from a phase I study that evaluated the safety profile, biodistribution, and dosimetry of [89Zr]Zr-DFO-girentuximab in Japanese patients with suspected RCC.

methodsEligible adult patients received 37 MBq (± 10%; 10 mg mass dose) of intravenous [89Zr]Zr-DFO-girentuximab. Safety and tolerability profile was assessed based on adverse events, concomitant medications, physical examination, vital signs, hematology, serum chemistry, urinalysis, human anti-chimeric antibody measurement, and 12-lead electrocardiograms at predefined intervals. Biodistribution and normal organ and tumor dosimetry were evaluated with PET/CT images acquired at 0.5, 4, 24, 72 h and Day 5 ± 2 d after administration.

results[89Zr]Zr-DFO-girentuximab was administered in six patients as per protocol. No treatment-emergent adverse events were reported. Dosimetry analysis showed that radioactivity was widely distributed in the body, and that the absorbed dose in healthy organs was highest in the liver (mean ± standard deviation) (1.365 ± 0.245 mGy/MBq), kidney (1.126 ± 0.190 mGy/MBq), heart wall (1.096 ± 0.232 mGy/MBq), and spleen (1.072 ± 0.466 mGy/MBq). The mean effective dose, adjusted by the radioactive dose administered, was 0.470 mSv/MBq. The radiation dose was highly accumulated in the targeted tumor, while any abnormal accumulation in other organs was not reported.

conclusionsThis study demonstrates that [89Zr]Zr-DFO-girentuximab administered to Japanese patients with suspected RCC has a favorable safety profile and is well tolerated and has a similar dosimetry profile to previously studied populations.

Indexed as

Carcinoma, Renal CellKidney NeoplasmsPositron Emission Tomography Computed TomographyRadioisotopesZirconiumAdultAgedAntibodies, MonoclonalEast Asian PeopleFemaleHumansJapanMaleMiddle AgedRadiopharmaceuticalsTissue DistributionAntibodies, MonoclonalRadioisotopesRadiopharmaceuticalsZirconiumZirconium-89[89Zr]Zr-DFO-girentuximab PET/CT imagingclear cell renal cell carcinomarenal cancer

Identifiers

PMID38864246
PMCPMC11322881

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Registered trials

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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.