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NCT Number: NCT06715020

Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging

The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Cancer Hospital & Institute

Beijing, 100143, China

Location status: Recruiting

Location contact

Zhi Yang

CONTACT

[email protected]

010-88196196

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);
  • Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC ≥ 4.0×109 L or neutrophil ≥1.5×109 /L, PLT ≥ 100×109/L, Hb≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver and kidney function: T-Bil ≤ 1.5×ULT(upper limit of normal), ALT and AST≤ 2.5 ULN or ≤ 5×ULT(subjects with liver metastasis), ALP ≤ 2.5 ULN(ALP ≤ 4.5 ULN if there is bone metastasis or liver metastasis); BUN ≤ 1.5×ULT, SCr ≤ 1.5×ULT;
  • Patients with confirmed or suspected breast cancer;
  • Expected survival ≥12 weeks;
  • Good follow-up compliance;
  • Women of childbearing age (15 to 49 years old) must undergo a pregnancy test within 7 days before the start of the test and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure pregnancy during the study period and within 3 months of the examination;
  • Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.

Exclusion criteria

  • Severe abnormal liver and kidney function;
  • Pregnant, pregnant and lactating women;
  • Can not lie flat for half an hour;
  • Unable to obtain informed consent;
  • Suffering from claustrophobia or other mental illness;
  • People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;
  • Other conditions deemed unsuitable for participation in the trial by the investigator.

Treatment and study plan

18F-FDG

Drug

[18F]FDG is administered intravenously as the comparator PET radiotracer. In the diagnostic validation cohort, participants undergo one [18F]FDG PET examination within 1 week of the [68Ga]Ga-TTP scan, with no treatment between scans. In the ADC response assessment cohort, participants undergo [18F]FDG PET imaging at the same three time points as [68Ga]Ga-TTP: before ADC therapy, after 2 cycles(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.1-0.15 mCi/kg.

[68Ga]Ga-TTP

Drug

[68Ga]Ga-TTP is a TROP2-targeted PET radiotracer administered intravenously for PET imaging. In the diagnostic validation cohort, participants undergo one [68Ga]Ga-TTP PET examination within 1 week of the comparator [18F]FDG scan. In the ADC response assessment cohort, participants undergo [68Ga]Ga-TTP PET imaging before ADC therapy, after 2 cycles of treatment(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.05-0.1 mCi/kg.

Primary outcomes

  1. Diagnostic performance of [68Ga]Ga-TTP PET compared with [18F]FDG PET for breast cancer lesions

    Time frame: Within 1 week after paired baseline imaging and within 2 months of follow-up/reference standard assessment

    To compare the diagnostic performance of [68Ga]Ga-TTP PET and [18F]FDG PET for breast cancer lesions, including sensitivity, specificity, accuracy, false-positive rate, and false-negative rate, using pathology and/or integrated follow-up assessment as reference standard.

  2. Change in [68Ga]Ga-TTP uptake in relation to ADC treatment response

    Time frame: Baseline before ADC therapy, at the end of Cycle 2 of ADC therapy (each cycle is 21 days), and from the start of ADC therapy until first documented disease progression, assessed up to 24 months.

    To evaluate the association between changes in tumor uptake on [68Ga]Ga-TTP PET (e.g., SUV or SUVmax) before treatment, after 2 cycles of TROP2-directed ADC therapy(each cycle is 21 days), and at disease progression, and clinical treatment response in patients with breast cancer receiving ADC therapy.assessed up to 24 months.

Secondary outcomes

  1. Correlation between [68Ga]Ga-TTP uptake and TROP2 expression in tumor tissue

    Time frame: At baseline PET/CT imaging and from 4 weeks before to 8 weeks after baseline imaging for pathological tissue assessment.

    To evaluate the correlation between standardized uptake values of [68Ga]Ga-TTP PET in target or suspected tumor lesions and TROP2 expression level in corresponding pathological tissue samples.

  2. Biodistribution and temporal distribution pattern of [68Ga]Ga-TTP in patients

    Time frame: From injection to 40 minutes post-injection for dynamic PET imaging; at 50-60 minutes post-injection for routine static PET/CT imaging; and at 2 hours post-injection and 3 hours post-injection for delayed PET/CT imaging in the dynamic-imaging subgroup.

    To assess the in vivo biodistribution, organ uptake, and temporal distribution characteristics of [68Ga]Ga-TTP in patients with breast cancer at different imaging time windows.

  3. Pathological results of lesions suspected to be positive on [68Ga]Ga-TTP PET

    Time frame: Within 2 months after imaging

    To assess the pathological findings of lesions suspected to be positive on [68Ga]Ga-TTP PET imaging, including concordance with biopsy or surgical pathology when available.

Study contacts

Contact information is provided by the study sponsor or research team.

Guojun Zhang

CONTACT

[email protected];

0871-68231187

Zhi Yang

CONTACT

[email protected]

010-88196196

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Collaborators

  • Yunnan Cancer Hospital

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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