99mTc-MIRC208 SPECT/CT Imaging for HER2-Positive Cancer Patients
A Novel VHH-Based Radiotracer, 99mTc-MIRC208, for SPECT/CT Imaging of HER2-Positive Cancer Patients
Study Overview
Detailed Description
HER2 is an important therapeutic target for cancer. Immunohistochemistry(IHC) and fluorescence in situ hybridization (FISH) are two standard approaches for HER2 status determination and selection of patients who will undergo the anti-HER2 therapy. However, the intra- and intratumor heterogeneity over space and time make them even more challenging to assess HER2 status. HER2-specific nuclear molecular imaging is a potential tool, which has ability to detect HER2 receptor in primary and metastatic lesions noninvasively and address the problems encountered by biopsy dependent tests. VHH, also referred to as nanobody, is a distinct type of antibody fragment derived from camelid heavy chain-only antibody. Compared with classical antibodies, VHHs have smaller size (about 15 kDa), greater thermal and chemical stability, which promoting their application in field of cancer theranostic.
In our recent preclinical studies, Principal Investigator developed a novel VHH-based radiotracer, 99mTc-MIRC208, for the SPECT/CT imaging of HER2 status in tumors. In this clinical study, Principal Investigator aim to investigate whether 99mTc-MIRC208 could be used for HER2 measurement in cancer patients. 99mTc-MIRC208 SPECT/CT examination will be performed in patients with HER2-positive tumors. The SUV of 99mTc-MIRC208 in tumors will be calculated. Meanwhile, Principal Investigator will investigate the ability of 99mTc-MIRC208 for the patients selection for anti-HER2 therapy.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100142
- Recruiting
- Hua Zhu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged # 18 years old; ECOG 0 or 1;
- Patients with HER2 positive or suspicious positive tumors;
- Has at least one measurable target lesion according to CT or MRI;
- Life expectancy ≥ 12 weeks.
Exclusion Criteria:
- Significant hepatic or renal dysfunction;
- Is pregnant or ready to pregnant;
- Cannot keep their states for half an hour;
- Refused to join the clinical research;
- Suffering from claustrophobia or other mental disorders;
- Any other situation that researchers considered it unsuitable to participate in the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 99mTc-MIRC208 SPECT/CT scan
The cancer patients will be injected with14.8
MBq/kg body weight, and 2h later, SPECT/CT scan will be performed.
|
99mTc-MIRC208 SPECT/CT: after intravenous injection of 14.8 MBq/kg body weight of quality-controlled 99mTc-MIRC208 2 h, a Siemens Symbia T16 SPECT/CT scan will be performed within 1 h.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SUV
Time Frame: 3 years
|
The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT
|
3 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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