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

NCT06715020 | Not Yet Recruiting

• 1 other identifier: 2024KT104
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value（SUV）

  The uptake of the tracer （68Ga-TTP） in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.

  2 years

Study Arms (1)

68Ga-TTP

EXPERIMENTAL

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

Drug: 18F-FDG

Interventions

18F-FDG DRUG

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

68Ga-TTP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead
• Yunnan Cancer Hospital: collaborator

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Central Study Contacts

Zhi Yang

CONTACT

010-88196196; pekyz@163.com

Guojun Zhang

CONTACT

0871-68231187; zhangguojun@kmmu.edu.cn;

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 4, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-12