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

NCT ID: NCT06715020

Last Updated: 2024-12-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-31
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-TTP

All study participants will be allocated to this arm (single-arm study).Study participants will undergo 68Ga-TTP PET scans

Group Type: EXPERIMENTAL

18F-FDG

Intervention Type: DRUG

All study participants will undergo one 18F-FDG PET scan.

Interventions

18F-FDG

All study participants will undergo one 18F-FDG PET scan.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age 18-75 years old, male or female, ECOG score 0 or 1 points (see the table in Annex 2 for the score table);

2. 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;

3. Patients with confirmed or suspected breast cancer;

4. Expected survival ≥12 weeks;

5. Good follow-up compliance;

6. 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;

7. Subject patients can fully understand and voluntarily participate in this experiment, and sign informed consent.

Exclusion Criteria

1. Severe abnormal liver and kidney function;

2. Pregnant, pregnant and lactating women;

3. Can not lie flat for half an hour;

4. Unable to obtain informed consent;

5. Suffering from claustrophobia or other mental illness;

6. People who are known to be allergic to the investigational drug or its excipients in the investigational therapy;

7. Other conditions deemed unsuitable for participation in the trial by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yunnan Cancer Hospital

OTHER

Sponsor Role: collaborator

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zhi Yang

Role: CONTACT

pekyz@163.com

010-88196196

Guojun Zhang

Role: CONTACT

zhangguojun@kmmu.edu.cn;

0871-68231187

Other Identifiers

2024KT104

Identifier Type: -

Identifier Source: org_study_id