NCT06362304

Brief Summary

The goal of this clinical trial is to evaluate the value of 99mTc-CNDG for diagnosis of brain tumors by comparing it with 18F-FDG-PET. The main questions it aims to answer are:

  1. 1.What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?
  2. 2.What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

April 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

April 20, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

November 25, 2024

Status Verified

November 1, 2024

Enrollment Period

10 months

First QC Date

April 9, 2024

Last Update Submit

November 21, 2024

Conditions

Intracranial Tumor

Outcome Measures

Primary Outcomes (1)

  • SUVmax

    1\. Diagnostic consistency evaluation of 99mTc-CNDG and 18F-FDG; 2.Correlation of SUV value of 99mTc-CNDGwith tumor type

    1month

Study Arms (1)

intracranial tumor

EXPERIMENTAL
Diagnostic Test: 99mTc-CNDG SPECT/CT

Interventions

99mTc-CNDG SPECT/CTDIAGNOSTIC_TEST

FDG-PET and 99mTc-CNDG will be performed within 2 weeks before surgery.

intracranial tumor

Eligibility Criteria

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

You may qualify if:

  • Patients with clinical diagnosis of brain tumor;
  • Be at least 18 years old;
  • The final pathological results could be obtained by surgery or biopsy;
  • Informed consent and the ability to be followed up;

You may not qualify if:

  • Insulin-dependent diabetes mellitus or fasting blood glucose \>7 mmol/L before 99mTc-CNDG injection;
  • Severe liver or kidney disease (serum creatinine level \>3.0mg/dL or any liver enzyme level ≥ 5 times the upper limit of normal);
  • Severe hypersensitivity or hypersensitivity to radiocontrast agents;
  • Claustrophobia (inability to undergo SPECT/CT or PET/CT scans);
  • Patients receiving radiotherapy and chemotherapy;
  • Being pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Zhaohui Zhu

CONTACT

0106915424113611093752@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 12, 2024

Study Start

April 20, 2024

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

November 25, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)