NCT06104085

99mTc-MY6349 SPECT/CT Imaging in Trop2-positive Triple-negative Breast Cancer

Recruiting now NA Last updated 27 October 2023

What this trial tests

NA trial testing 99mTc-MY6349 SPECT/CT scan in Breast Cancer in 30 participants. Currently enrolling.

Timeline

13 September 2023

Primary endpoint
1 October 2026

31 December 2026

Quick facts

Lead sponsor	Peking Union Medical College Hospital
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	30
Start date	13 September 2023
Primary completion	1 October 2026
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

• 99mTc-MY6349 SPECT/CT scan

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 80, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Human trophoblast cell-surface glycoprotein antigen 2 (Trop2) is a membrane surface receptor that plays an important role in the occurrence and development of tumors. Studies have shown that Trop2 is highly expressed in a variety of cancers (such as breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer, and ovarian cancer, etc.) and is related to the proliferation, invasion, and metastasis of tumor cells. and other processes related. According to statistics, more than 80% of breast cancer patients highly express Trop2, and high expression of Trop2 is positively correlated with shortened survival and poor prognosis of cancer patients. In this study, a single-domain antibody targeting Trop2 was selected to prepare a new nuclear medicine molecular probe 99mTc-MY6349, so as to monitor the expression level of Trop2 in patients' systemic tumors through SPECT/CT imaging. Breast cancer patients who intend to use gosatuzumab for subsequent treatment can first undergo 99mTc-MY6349 SPECT/CT imaging to detect Trop2 expression levels in systemic tumors. Subsequently, 18F-FDG PET/CT imaging was performed to compare and detect the distribution of primary tumors and systemic metastases in patients with breast cancer. This study analyzes the heterogeneity of Trop2 expression levels within the primary tumor and the heterogeneity of expression levels in systemic metastases, thereby providing a basis for testing whether the patient is suitable for subsequent treatment and conducive to the formulation of subsequent treatment plans.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell surface oncofetal antigens in prostate cancer: therapeutic potential and radioligand targeting.
   Harbi E, Bilgin GB, Emmett L, Kendi AT, et al · · 2026 · PMID 41832388 · DOI 10.1186/s13550-026-01396-x
2. Current Approaches of Nuclear Molecular Imaging in Breast Cancer.
   Schäfer L, Altunay B, Heesch A, van Nijnatten T, et al · · 2025 · PMID 40647404 · DOI 10.3390/cancers17132105