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RecruitingNCT05982626Updated Apr 24, 2024

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

An interventional study of 68Ga/131I-SGMIB-ZT-199 in HER2-positive Breast Cancer, sponsored by Huashan Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-24.

Sponsored by Huashan Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • HER2-positive Breast Cancer

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Keywords

  • Her2-positive
  • Metastatic breast cancer
  • Positron-Emission Tomography
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 10 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 239 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Breast cancer patients.

    1. Women aged between 18 and 75 years old.
    2. Patients with breast cancer confirmed by histological examination or imaging.
    3. 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+)).
    4. Renal function: serum creatinine less than or equal to the upper limit of the normal range; electrocardiogram: no significant abnormalities.
    5. Patients of childbearing age can cooperate with contraception.
    6. Willing and able to cooperate with all items of this study.

Exclusion criteria

Exclusion Criteria:

  • Subjects meeting any of the following criteria will be excluded from the study:

    1. Severe hepatic or renal insufficiency;
    2. 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.
    3. Participation in this study is considered unsuitable by other investigators.
    4. Pregnant women and other groups unsuitable to receive radiation.
    5. Alcohol allergy, etc.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    68Ga/131I-SGMIB-ZT-199

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

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

Interventions

  • Radiation68Ga/131I-SGMIB-ZT-199

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

06

What researchers measure

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.

    Time frame: about 24hours from time of injection

Secondary outcomes

  1. Safety Assessment

    Incidence and severity of adverse events (AEs) as assessed by CTCAE v4.0

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

07

Study locations

1 of 1 sites recruiting
  • Huashan Hospital
    Shanghai, 200040, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05982626
Lead sponsor
Huashan Hospital
Responsible party
YiHui Guan (Professor, Huashan Hospital) — Principal investigator
First posted
Aug 8, 2023
Start date
May 15, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Apr 24, 2024

Study contacts

Yihui Guan, MD
Contact
guanyihui@hotmail.com
13764308300 ext. +86
Fang Xie, PhD
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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