99mTc-MIRC208 SPECT/CT Imaging for HER2-Positive Cancer Patients

Cancer Clinical Trial

Official title:

A Novel VHH-Based Radiotracer, 99mTc-MIRC208, for SPECT/CT Imaging of HER2-Positive Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591652
• Other study ID #: 2020KT81
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: August 30, 2024

Study information

• Verified date: March 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-labeled Single-Photon Emission Computed Tomography/Computed Tomography(SPECT/CT) study to investigate the clinical value of 99mTc-MIRC208 in HER2 status measurement of cancer patients. A single dose of 14.8 MBq/kg body weight will be injected intravenously. The whole-body SPECT/CT examination will be performed 2 h post-injection and the visual and semiquantitative methods will be used to assess the SPECT/CT images.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Aged # 18 years old; ECOG 0 or 1;

2. Patients with HER2 positive or suspicious positive tumors;

3. Has at least one measurable target lesion according to CT or MRI;

4. Life expectancy = 12 weeks.

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;

2. Is pregnant or ready to pregnant;

3. Cannot keep their states for half an hour;

4. Refused to join the clinical research;

5. Suffering from claustrophobia or other mental disorders;

6. Any other situation that researchers considered it unsuitable to participate in the trial.

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• 99mTc-MIRC208
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.

Locations

Country	Name	City	State
China	Hua Zhu	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUV	The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT	3 years