Study of 68Ga /131I SGMIB-ZT-199 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer

NCT05982626 | Recruiting DMC

• 1 other identifier: KY2023-545
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, biodistribution, radiation dosimetry, and uptake in tumor lesions of patients with Her2-positive metastatic breast cancer after injection of \[131I\]/\[68Ga\]SGMIB-ZT-199.

Conditions

HER2-positive Breast Cancer

Keywords

Her2-positive; Metastatic breast cancer; Positron-Emission Tomography

Outcome Measures

Primary Outcomes (1)

• Dosimetry

  To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from \[131I\]SGMIB-ZT-199, assessed by PET/SPECT imaging.

  about 24hours from time of injection

Secondary Outcomes (1)

• Safety Assessment

  From administration of [131I]SGMIB-ZT-199 until 1 week after injection

Study Arms (1)

68Ga/131I-SGMIB-ZT-199

EXPERIMENTAL

68Ga/131I-SGMIB-ZT-199, single dose

Radiation: 68Ga/131I-SGMIB-ZT-199

Interventions

68Ga/131I-SGMIB-ZT-199 RADIATION

68Ga-SGMIB-ZT-199: PET imaging; 131I-SGMIB-ZT-199: SPECT imaging.

68Ga/131I-SGMIB-ZT-199

Eligibility Criteria

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

You may qualify if:

• Breast cancer patients.
• Women aged between 18 and 75 years old.
• Patients with breast cancer confirmed by histological examination or imaging.
• HER2 positive diagnosis confirmed by puncture by immunohistochemistry or fluorescence in situ hybridization (HER2 positive is defined as immunohistochemistry result of 3+ (IHC 3+); or immunohistochemistry result of 2+/positive in situ hybridization result (IHC 2+/ISH+)).
• Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities.
• Patients of childbearing age can cooperate with contraception.
• Willing and able to cooperate with all items of this study.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from the study:
• Severe hepatic or renal insufficiency;
• Participation in another study protocol or clinical care within the past year that has resulted in radiation exposure exceeding an effective dose of 50 mSv in addition to the radiation exposure expected from participation in this clinical study.
• Participation in this study is considered unsuitable by other investigators.
• Pregnant women and other groups unsuitable to receive radiation.
• Alcohol allergy, etc.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Fang Xie, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

13764308300; guanyihui@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: August 8, 2023
• Study Start: May 15, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

CN (1)