CancerNCT03721055
Fluoroglutamine PET/CT in Imaging Patients With Malignant Tumor
A study testing 18F-(2S,4R)4-fluoroglutamine in people with Cancer and Metastatic Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with malignant tumor. [18F]Fluoroglutamine PET may provide additional information that help diagnose and stage cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Cancer, Metastatic Cancer, Metastatic Brain Cancer
- What is being tested?
- 18F-(2S,4R)4-fluoroglutamine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2017to 31 Dec 2019
- Phase
- Interventional
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-79;
- The patient must be able to give informed consent;
- Patients can finish PET/CT scan without tranquilizers;
- Patients with pathology-proven cancer or a tumor highly suspected to be malignant ;
- Lesions can be measured and assessed at the RECIST 1.1 standard;
- No chemotherapy, radiotherapy or immune/biologic therapy,or biopsy were allowed between the 18F-FDG and the 4-[18F]Fluoroglutamine PET/CT.
Who cannot join
- Pregnant or lactating patients;
- Inability or refusal to have at least one peripheral intravenous line for intravenous access;
- From assays obtained <2 weeks prior to study enrollment（ULN：the upper limit of normal value ）:Bilirubin>1.5*ULN,AST/ALT >2.5 * ULN, Albumin< 3 g/dl, GGT > 2.5 x ULN if ALP> 2.5 x ULN, Creatinine>1.5*ULN or creatinine clearance <60ml/min；
- Patients with a history of allergic reaction to this drugs or its analogues；
- patients with poor compliance;
- Acute major illness
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital
Shanghai, Shanghai Municipality, 200092
Hui Wang, MD, 86-02125078590, wanghauishanghai@hotmail.com
About this study
Official title: 18F-(2S,4R)4-Glutamine PET/CT in Imaging Patients With Malignant Tumor
This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with malignant tumor. [18F]Fluoroglutamine PET may provide additional information that help diagnose and stage cancer patients.
- Conditions
- Cancer, Metastatic Cancer, Metastatic Brain Cancer
- Being tested
- 18F-(2S,4R)4-fluoroglutamine
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-(2S,4R)4-fluoroglutamineRadiation
Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 4-[18F]Fluoroglutamine | Experimental | Patients undergo 18F-FDG PET/CT scan first. Within 7 working days, patients receive 4-[18F]Fluoroglutamine IV and 60 minutes after injection, undergo 4-[18F]Fluoroglutamine PET/CT before the start of therapy. Receives: Radiation: 18F-(2S,4R)4-fluoroglutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer
Sensitivity, specificity, diagnostic accuracy of 4-[18F]Fluoroglutamine and 18F-FDG PET/CT will be compared using paired t-test or Krusal-Wallis test.
Measured: up to three years
Secondary outcomes (3)
Incidence of Treatment-Emergent Adverse Events
The evaluation of the Incidence of Treatment-Emergent Adverse Events starts from the day of F-Gln examination until 30 days later; Treatment-Emergent Adverse Events are evaluated according to version 4.03 CTC-AE criteria.
Measured: up to 30 days after the F-Gln imaging
ASCT2 expression levels in tissue samples
Wilcoxon rank-sum or Kruskal-Wallis tests will be applied for the group comparisons of IHC staining(ASCT2)
Measured: up to three years
The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors
Evaluating the prognostic value of metabolic parameters and clinical indexes by using log-rank tests on univariate analysis and COX proportional hazards regression tests
Measured: up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start21 Aug 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721055
- Sponsor's protocol ID
- XHEC-C-2017-029-2
- Status last verified
- Aug 2019
- First submitted
- 24 Oct 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-(2S,4R)4-Glutamine PET/CT in Imaging Patients With Malignant Tumor
- ClinicalTrials.gov ID
- NCT03721055
- Acronym / sponsor ID
- XHEC-C-2017-029-2
- Conditions
- Cancer, Metastatic Cancer, Metastatic Brain Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Oct 2018 (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.
This clinical trial studies positron emission tomography (PET) imaging utilizing 18F-(2S,4R)4-fluoroglutamine, a glutamic acid derivative, to image patients with malignant tumor. [18F]Fluoroglutamine PET may provide additional information that help diagnose and stage cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4-[18F]Fluoroglutamine | Experimental | Radiation: 18F-(2S,4R)4-fluoroglutaminePatients undergo 18F-FDG PET/CT scan first. Within 7 working days, patients receive 4-[18F]Fluoroglutamine IV and 60 minutes after injection, undergo 4-[18F]Fluoroglutamine PET/CT before the start of therapy. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18-79;
- The patient must be able to give informed consent;
- Patients can finish PET/CT scan without tranquilizers;
- Patients with pathology-proven cancer or a tumor highly suspected to be malignant ;
- Lesions can be measured and assessed at the RECIST 1.1 standard;
Key exclusion criteria (6 listed)
- Pregnant or lactating patients;
- Inability or refusal to have at least one peripheral intravenous line for intravenous access;
- From assays obtained <2 weeks prior to study enrollment（ULN：the upper limit of normal value ）:Bilirubin>1.5*ULN,AST/ALT >2.5 * ULN, Albumin< 3 g/dl, GGT > 2.5 x ULN if ALP> 2.5 x ULN, Creatinine>1.5*ULN or creatinine clearance <60ml/min；
- Patients with a history of allergic reaction to this drugs or its analogues；
- patients with poor compliance;
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 |
|---|---|---|
| 18F-(2S,4R)4-fluoroglutamineUndergo 18F-(2S,4R)4-fluoroglutamine PET/CT | Radiation | 4-[18F]Fluoroglutamine |
Primary outcome
Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer
Time frame: up to three years
Sensitivity, specificity, diagnostic accuracy of 4-[18F]Fluoroglutamine and 18F-FDG PET/CT will be compared using paired t-test or Krusal-Wallis test.
3 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: up to 30 days after the F-Gln imaging
ASCT2 expression levels in tissue samples
Time frame: up to three years
The correlation between 18F-(2S,4R)4- glutamine PET/CT imaging and prognosis in malignant tumors
Time frame: up to three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-(2S,4R)4-fluoroglutamine in people with Cancer and Metastatic Cancer, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 6 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: status not confirmed, as of the sponsor's last update on 6 Sep 2019. 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 Hui Wang, MD (86-02125078590, wanghauishanghai@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosing and Staging ability of 4-[18F]Fluoroglutamine PET/CT in malignant cancer (time frame: up to three years). 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 6 Sep 2019.