NCT04591652

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

October 16, 2020

Last Update Submit

March 27, 2023

Conditions

Cancer

Keywords

HER2VHHSPECT/CT

Outcome Measures

Primary Outcomes (1)

  • SUV

    The uptake of the tracer in the primary and metastatic tumor lesions by measuring standardized uptake value (SUV) on PET/CT

    3 years

Study Arms (1)

99mTc-MIRC208 SPECT/CT scan

EXPERIMENTAL

The cancer patients will be injected with14.8 MBq/kg body weight, and 2h later, SPECT/CT scan will be performed.

Drug: 99mTc-MIRC208

Interventions

99mTc-MIRC208DRUG

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.

99mTc-MIRC208 SPECT/CT scan

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hua Zhu

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

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
Associate Professor

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 19, 2020

Study Start

September 1, 2020

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)