Noninvasive Evaluation of HER2 Expression and Heterogeneity in Urothelial Carcinoma on 68 Ga-HER2-affibody PET/CT

Q: What is the purpose of using 68Ga-HER2 affibody PET/CT in urothelial carcinoma?

To evaluate the feasibility of noninvasively assessing HER2 expression and tumor heterogeneity, and to explore its utility for guiding HER2-targeted therapy.

Q: How were patients and imaging studies conducted?

Thirty-two urothelial carcinoma patients underwent 68Ga-HER2-affibody PET/CT and 18F-FDG PET/CT prospectively from September 2024 to April 2025, with semiquantitative PET/CT parameters analyzed across HER2 status.

Q: Which findings support the ability to differentiate HER2 status?

HER2-positive patients had significantly higher 68Ga-HER2 PET/CT uptake and related metrics than HER2-negative patients, and ROC analysis showed strong predictive value for HER2-SUVmax and TMR.

Sep 29, 2026

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Noninvasive assessment of HER2 status and intratumoral heterogeneity in urothelial carcinoma is evaluated using 68Ga-HER2 afﬁbody PET/CT. Thirty-two patients with urothelial carcinoma underwent 68Ga-HER2-afﬁbody and 18F-FDG PET/CT prospectively, with semiquantitative metrics including SUVmax, SUVmean, TMR, HER2-TV/MTV, and TL-HER2/TLG analyzed across HER2 expression categories. HER2-positive disease showed higher uptake and volume-related measures, while intrapatient lesion variability was quantified using SUVmax CV. ROC analysis supported predictive performance for HER2-negative versus positive classification, and heterogeneity was notable across metastatic lesions.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages9

Reading Time23 min

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Purpose

Patients and Methods

Results

Conclusions

Background and Rationale

ORIGINAL ARTICLE Noninvasive Evaluation of HER2 Expression and Heterogeneity in Urothelial Carcinoma on 68 Ga-HER2- affibody PET/CT Zihao Tao, MD,* Xueqi Chen, MD,† Qi Tang, MD,* Xiaojiang Duan, PhD,† Lei Yin, MD,† Hongyun Li, MD,† Xiaoying Li, MD,‡ Jianhua Zhang, MD,† and Xuesong Li, MD* Purpose: Human epidermal growth factor receptor 2 (HER2) is a promising therapeutic target in urothelial carcinoma (UC) . We aimed to evaluate the feasibility of 68Ga-HER2 afﬁbody PET/CT in assessing HER2 expression and tumor heterogeneity, and to explore its utility for guiding HER2-targeted therapy in UC. Patients and Methods: Thirty-two patients with UC who underwent 68Ga-HER2-afﬁbody and 18F-FDG-PET/CT were prospectively recruited from September 2024 to April 2025 . Semiquantitative PET/CT parameters (SUVmax, SUVmean, TMR, HER2-TV/ MTV, and TL-HER2/TLG) were analyzed across HER2 statuses. Intrapatient heterogeneity of SUVmax across lesions was assessed by the coefﬁcient of variation (CV) . Results: HER2-positive patients demonstrated signiﬁcantly higher SUVmax, SUVmean, TMR, and HER2-TV of 68Ga-HER2-afﬁbody PET/CT compared with HER2-negative patients (all P < Received for publication September 21, 2025; accepted October 20, 2025 . From the *Department of Urology, Peking University First Hospital, Institution of Urology, Peking University; Departments of †Nuclear Medicine; and ‡Radiation Oncology, Peking University First Hospital, Beijing, China. Z.T., X.C., and Q.T. contributed equally to this work. Conﬂicts of interest and sources of funding: none declared. This study was supported by National High Level Hospital Clinical Research Funding (Interdepartmental Research Project of Peking University First Hospital) (grant number: 2024IR06), Peking University Clinical Scientist Training Program (grant number: BMU2025PYJH006), National High Level Hospital Clinical Research Funding (Scientiﬁcand Technological Achievements Transformation Incubation Guidance Fund Project of Peking University First Hospital) (grant number: 2025CX30), Youth Clinical Research Project of Peking University First Hospital (grant number: 2024YC24), Beijing Cancer Prevention and Treatment Research Association Fund (grant number: KY202501029, KY202501004), Capital Health Development Research Special Project (grant number: 2024-1-4072) and National High Level Hospital Clinical Research Funding ( Youth Clinical Research Project of Peking University First Hospital) ( grant number: 2025YC-GD03) . Correspondence to: Xuesong Li, MD, Department of Urology, Peking University First Hospital, Institution of Urology, Peking University, Beijing 100034, China. E-mail: [pineneedle@sina.com](pineneedle@sina.com); Jianhua Zhang, MD, Department of Nuclear Medicine, Peking University First Hospital, Beijing 100034, [China. E-mail: zjhjn820@163.com](China. E-mail: zjhjn820@163.com); Xiaoying Li, MD, Department of Radiation Oncology, Peking University First Hospital, Beijing 100034, [China. E-mail: mermaidlxy@sina.com](China. E-mail: mermaidlxy@sina.com). Supplemental Digital Content is available for this article. Direct URL citations are provided in the HTML and PDF versions of this article on the journal’s website, [www.nuclearmed.com](www.nuclearmed.com). Copyright © 2025 The Author(s) . Published by Wolters Kluwer Health, Inc. This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. DOI: 10.1097/RLU.0000000000006239 0.05) . No signiﬁcant differences were observed in 18F-FDG PET/CT except for MTV and TLG (P < 0.05) . ROC analysis revealed strong predictive value for HER2-SUVmax (AUC: 0.87) and TMR (AUC: 0 . 88) in differentiating HER2-negative/positive. Stepwise increases in HER2-PET/CT

FAQs

What is the purpose of using 68Ga-HER2 affibody PET/CT in urothelial carcinoma?

To evaluate the feasibility of noninvasively assessing HER2 expression and tumor heterogeneity, and to explore its utility for guiding HER2-targeted therapy.

How were patients and imaging studies conducted?

Thirty-two urothelial carcinoma patients underwent 68Ga-HER2-affibody PET/CT and 18F-FDG PET/CT prospectively from September 2024 to April 2025, with semiquantitative PET/CT parameters analyzed across HER2 status.

Which findings support the ability to differentiate HER2 status?

HER2-positive patients had significantly higher 68Ga-HER2 PET/CT uptake and related metrics than HER2-negative patients, and ROC analysis showed strong predictive value for HER2-SUVmax and TMR.

Sep 29, 2026

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