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

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About this study

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.

Condition
Breast Cancer
Tested
18F-FDG, [68Ga]Ga-TTP
Sponsor
Peking University Cancer Hospital & Institute

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Breast Cancer
  • 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 7

  • 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.

Where

1 site, 1 recruiting

Peking University Cancer Hospital & Institute

Beijing, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.