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Study of 68Ga /131I SGMIB-5F7 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer

Sponsor
Huashan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05982626
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
6.5
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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-5F7.

Condition or Disease Intervention/Treatment Phase
  • Radiation: 68Ga/131I-SGMIB-5F7
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of 68Ga /131I SGMIB-5F7 PET Imaging Targeting HER2-positive in the Diagnosis of Metastatic Breast Cancer
Anticipated Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Feb 14, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga/131I-SGMIB-5F7

68Ga/131I-SGMIB-5F7, single dose

Radiation: 68Ga/131I-SGMIB-5F7
68Ga-SGMIB-5F7: PET imaging; 131I-SGMIB-5F7: SPECT imaging.

Outcome Measures

Primary Outcome Measures

  1. Dosimetry [about 24hours from time of injection]

    To confirm biodistribution and absorbed doses of whole body, tumor lesions, and organs from [131I]SGMIB-5F7, assessed by PET/SPECT imaging.

Secondary Outcome Measures

  1. Safety Assessment [From administration of [131I]SGMIB-5F7 until 1 week after injection]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Huashan Hospital Shanghai China 200040

Sponsors and Collaborators

  • Huashan Hospital

Investigators

  • Principal Investigator: Fang Xie, PhD, Huashan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
YiHui Guan, Professor, Huashan Hospital
ClinicalTrials.gov Identifier:
NCT05982626
Other Study ID Numbers:
  • KY2023-545
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by YiHui Guan, Professor, Huashan Hospital
Her2-positive
Metastatic breast cancer
Positron-Emission Tomography
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Aug 8, 2023