Intracranial TumorNCT06362304
99mTc-CNDG SPECT/CT in Brain Tumors
A study testing 99mTc-CNDG SPECT/CT in people with Intracranial Tumor, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Tumor
- What is being tested?
- 99mTc-CNDG SPECT/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2024to Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Those who did not meet the exclusion criteria.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Zhaohui Zhu, 010-69154241, 13611093752@163.com
About this study
Official title: Application of 99mTc-CNDG SPECT/CT Imaging in the Diagnosis of Brain Tumors
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:
- What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?
- What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?
Participants will:
Receive18F-FDG-PET and 99mTc-CNDG examination within 2 weeks before surgery. Obtain pathological diagnosis by surgery or biopsy as the gold standard.
- Conditions
- Intracranial Tumor
- Being tested
- 99mTc-CNDG SPECT/CT
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTc-CNDG SPECT/CTDiagnostic test
FDG-PET and 99mTc-CNDG will be performed within 2 weeks before surgery.
| Study group | Role | What they receive |
|---|---|---|
| intracranial tumor | Experimental | Not described Receives: Diagnostic Test: 99mTc-CNDG SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
- Diagnostic consistency evaluation of 99mTc-CNDG and 18F-FDG; 2.Correlation of SUV value of 99mTc-CNDGwith tumor type
Measured: 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start20 Apr 2024
- Primary completionFeb 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial TumorStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362304
- Sponsor's protocol ID
- 2024-DG-01
- Status last verified
- Nov 2024
- First submitted
- 9 Apr 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 99mTc-CNDG SPECT/CT Imaging in the Diagnosis of Brain Tumors
- ClinicalTrials.gov ID
- NCT06362304
- Acronym / sponsor ID
- 2024-DG-01
- Conditions
- Intracranial Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?
- What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?
Participants will:
Receive18F-FDG-PET and 99mTc-CNDG examination within 2 weeks before surgery. Obtain pathological diagnosis by surgery or biopsy as the gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intracranial tumor | Experimental | Diagnostic Test: 99mTc-CNDG SPECT/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- Those who did not meet the exclusion criteria.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTc-CNDG SPECT/CTFDG-PET and 99mTc-CNDG will be performed within 2 weeks before surgery. | Diagnostic test | intracranial tumor |
Primary outcome
SUVmax
Time frame: 1month
1. Diagnostic consistency evaluation of 99mTc-CNDG and 18F-FDG; 2.Correlation of SUV value of 99mTc-CNDGwith tumor type
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-CNDG SPECT/CT in people with Intracranial Tumor, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Zhu (01069154241, 13611093752@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: 1month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.