GliomaGNNGBNCT02327442
68Ga-NOTA-NFB: Radiation Dosimetry in Healthy Volunteers and Applications in Glioma Patients or Breast Cancer Patients
An observational study of Glioma and Breast Cancer, run by Xijing Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the safety, biodistribution, dosimetric properties of the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To preliminarily evaluate its application in glioma diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Glioma, Breast Cancer
- What is being tested?
- 68Ga-NOTA-NFB
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- Jun 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 6 healthy volunteers. 10 patients with glioma before surgery. 30 patients with breast cancer before and after neoadjuvant chemotherapy.
Who may be able to join
- volunteers : healthy patients with glioma: diagnosed by MR and ready for surgery patients with breast: cancer appropritate of neoadjuvant chemotherapy.
Who cannot join
- patients with glioma: refuse or cannot endure surgery. patients with breast: refuse neoadjuvant chemotherapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing Hospital Nuclear Medicine Department
Xi'an, Shaanxi, 710032
Jing Wang, Doctor, 86-29-84775449, wangjing@fmmu.edu.cn
About this study
Official title: Prospective Imaging Study of 68Ga-NOTA-NFB in Tumors
The purpose of this study is to assess the safety, biodistribution, dosimetric properties of the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To preliminarily evaluate its application in glioma diagnosis.
To assess the application of 68Ga-NOTA-NFB PET/CT in the evaluation of the neoadjuvant chemotherapy in patients with breast cancer before and after the therapy.
Read the detailed description
6 healthy volunteers with whole-body PET/CT scans 0, 0.5, 1.0, 2.0, and 3.0 hours after tracer injection (mean dose, 4.93 ± 0.10 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.
8-10 patients with glioma will be enrolled for the clinical study of diagnosing glioma, they will be performed with both 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before surgery. The preoperative images are compared and correlated with the pathologically report. Next, the expression of CXCR4 will be determined by immunohistochemical staining of the resected brain tumor tissues.
30 patients with breast cancer will be underwent 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before and after the neoadjuvant chemotherapy. SUV of lesions before and after therapy will be contrasted.
- Conditions
- Glioma, Breast Cancer
- Being tested
- 68Ga-NOTA-NFB
- Keywords
- chemokine receptor, galium, dosimetry, glioma
- Medical subject headings
- Glioma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-NOTA-NFBRadiation
In this investigation, 68Ga-NOTA-NFB is employed to a preclinical trial, including radiation dosimetry study in healthy volunteers and the first application in glioma patients, to assess the safety, dosimetry property and evaluate the CXCR4 expression in glioma patients and breast cancer patients.
| Study group | Role | What they receive |
|---|---|---|
| Volunteers | Healthy Volunteers undergo whole-body 68Ga-NOTA-NFB PET/CT scans 0, 0.5, 1.0, 2.0, and 3.0 hours after tracer injection. During the imaging period, 1 mL blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-activity curve calculations. Receives: Radiation: 68Ga-NOTA-NFB | |
| Glioma Patients | Glioma Patients enrolled for the clinical study of diagnosing glioma are performed with both 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before surgery. Receives: Radiation: 68Ga-NOTA-NFB | |
| Breast Cancer Patients | 68Ga-NOTA-NFB PET/CT and 18F-FDG PET/CT scans will undergo in patients with breast cancer before and after neoadjuvant chemotherapy. Receives: Radiation: 68Ga-NOTA-NFB |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV of organs
The standardized uptake values (SUV) in deferent organs are calculated.
Measured: 0, 0.5, 1.0, 2.0, and 3.0hours after injection
radioactivity of blood sample
blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-radioactivity curve calculations.
Measured: 1, 3, 5, 10, 30,60, 90, 120, 150, and 180minutes
SUV of glioma
The maximum standardized uptake values (SUVmax) and the maximum target to non-target ratios (T/NTmax) of 68Ga-NOTA-NFB and 18F-FDG in glioma tissues.
Measured: 1 hour after injection
SUV of Breast Cancer
The maximum standardized uptake values (SUVmax) of 68Ga-NOTA-NFB and 18F-FDG in breast cancer before and after neoadjuvant chemotherapy.
Measured: 1 hour after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Wang, Doctor, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327442
- Sponsor's protocol ID
- KY20140522-6
- Acronym
- GNNGB
- Status last verified
- Dec 2014
- First submitted
- 23 Dec 2014
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Imaging Study of 68Ga-NOTA-NFB in Tumors
- ClinicalTrials.gov ID
- NCT02327442
- Acronym / sponsor ID
- GNNGB / KY20140522-6
- Conditions
- Glioma, Breast Cancer
- Keywords
- chemokine receptor, galium, dosimetry, glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 30 Dec 2014 (estimated)
- 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 purpose of this study is to assess the safety, biodistribution, dosimetric properties of the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To preliminarily evaluate its application in glioma diagnosis.
To assess the application of 68Ga-NOTA-NFB PET/CT in the evaluation of the neoadjuvant chemotherapy in patients with breast cancer before and after the therapy.
Detailed description
6 healthy volunteers with whole-body PET/CT scans 0, 0.5, 1.0, 2.0, and 3.0 hours after tracer injection (mean dose, 4.93 ± 0.10 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.
8-10 patients with glioma will be enrolled for the clinical study of diagnosing glioma, they will be performed with both 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before surgery. The preoperative images are compared and correlated with the pathologically report. Next, the expression of CXCR4 will be determined by immunohistochemical staining of the resected brain tumor tissues.
30 patients with breast cancer will be underwent 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before and after the neoadjuvant chemotherapy. SUV of lesions before and after therapy will be contrasted.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Volunteers | – | Radiation: 68Ga-NOTA-NFBHealthy Volunteers undergo whole-body 68Ga-NOTA-NFB PET/CT scans 0, 0.5, 1.0, 2.0, and 3.0 hours after tracer injection. During the imaging period, 1 mL blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-activity curve calculations. |
| Glioma Patients | – | Radiation: 68Ga-NOTA-NFBGlioma Patients enrolled for the clinical study of diagnosing glioma are performed with both 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before surgery. |
| Breast Cancer Patients | – | Radiation: 68Ga-NOTA-NFB68Ga-NOTA-NFB PET/CT and 18F-FDG PET/CT scans will undergo in patients with breast cancer before and after neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 6 healthy volunteers. 10 patients with glioma before surgery. 30 patients with breast cancer before and after neoadjuvant chemotherapy.
Key inclusion criteria (1 listed)
- volunteers : healthy patients with glioma: diagnosed by MR and ready for surgery patients with breast: cancer appropritate of neoadjuvant chemotherapy.
Key exclusion criteria (1 listed)
- patients with glioma: refuse or cannot endure surgery. patients with breast: refuse neoadjuvant 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 |
|---|---|---|
| 68Ga-NOTA-NFBIn this investigation, 68Ga-NOTA-NFB is employed to a preclinical trial, including radiation dosimetry study in healthy volunteers and the first application in glioma patients, to assess the safety, dosimetry property and evaluate the CXCR4 expression in glioma patients and breast cancer patients. | Radiation | Breast Cancer Patients, Glioma Patients, Volunteers |
Primary outcome
SUV of organs
Time frame: 0, 0.5, 1.0, 2.0, and 3.0hours after injection
The standardized uptake values (SUV) in deferent organs are calculated.
radioactivity of blood sample
Time frame: 1, 3, 5, 10, 30,60, 90, 120, 150, and 180minutes
blood samples are obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-radioactivity curve calculations.
SUV of glioma
Time frame: 1 hour after injection
The maximum standardized uptake values (SUVmax) and the maximum target to non-target ratios (T/NTmax) of 68Ga-NOTA-NFB and 18F-FDG in glioma tissues.
SUV of Breast Cancer
Time frame: 1 hour after injection
The maximum standardized uptake values (SUVmax) of 68Ga-NOTA-NFB and 18F-FDG in breast cancer before and after neoadjuvant chemotherapy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2014.
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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. This study is not recruiting at the moment.
Jing Wang, Doctor study director
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma and Breast Cancer, run by Xijing 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Dec 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Wang, Doctor (86-29-84775449, wangjing@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUV of organs (time frame: 0, 0.5, 1.0, 2.0, and 3.0hours after injection). The study lists 4 primary outcomes in all. 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 30 Dec 2014.