Solid Tumor, AdultNCT05538676
Fluoride-labeled Boronophenylalanine PET Imaging in Patients With Solid Tumors
An observational study of Solid Tumor, Adult, run by Xiaohua Zhu at 1 site in China.
Trial summary
Recently, new high-dose radiation therapy [e.g., boron neutron capture therapy (BNCT)] absorbed into the tumor tissue has been applied to treat patients with solid tumors. Here we examine and describe how to evaluate the biological activity of tumors using positron emission tomography (PET) with fluoride-labeled… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- BPA-PET imaging
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 26 Dec 2022to 25 Aug 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with diagnosed solid tumor
Who may be able to join
- patients with clinically diagnosed solid tumors, including but not limited to recurrent head and neck cancer, glioma, pancreatic cancer, osteosarcoma, etc.; The selected subjects need to sign the informed consent.
Who cannot join
- Pregnant women; renal failure (serum Cr>3mg/dl); Patients with claustrophobia;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
TongjiHospital
Wuhan, Hubei, 430030
xiaohua zhu, Dr., 13971513770 ext. 86, evazhu@vip.sina.com
About this study
Recently, new high-dose radiation therapy [e.g., boron neutron capture therapy (BNCT)] absorbed into the tumor tissue has been applied to treat patients with solid tumors. Here we examine and describe how to evaluate the biological activity of tumors using positron emission tomography (PET) with fluoride-labeled boronophenylalanine (F-BPA) as a tracer.
Read the detailed description
Boron Neutron Capture Therapy（BNCT） is an advanced cell-scale binary targeted radiotherapy technology that combines the advantages of targeted therapy and heavy ion therapy. BNCT provides a neutron source from a reactor or a medical accelerator. At the same time, the patient needs to be pre-injected with a boron-containing drug containing a non-radioactive boron 10 isotope. The boron drug enters the body and accumulates specifically in cancer cells. The patient receives epithermal neutron beam irradiation with high linear energy transfer (Linear EnergyTransferLET), thereby achieving the effect of killing tumor cells. Purpose，BNCT has more advantages over conventional radiotherapy, and normal tissue is better preserved than conventional radiotherapy.
PET imaging is a useful and effective technique to give absolute quantitative and biological distribution data of BPA in a non-invasive manner, and can add important characteristic parameters such as T/N ratio, SUV and Kinetic parameters. Given the complexity of BNCT, PET and PET/CT is currently the new standard for designing patient recruitment: The Methodology of L-18F-BPA PET is an important tool to design clinical trials , estimate the size of tumor and indicate the concentration ratio of BPA in surrounding normal tissues. Following this principle, researchers can accurately identify which patients can benefit from BNCT treatment through the selective accumulation of BPA in individual tumors. PET scans can provide a three-dimensional map of the boron distribution, which can be used for macroscopic dose calculations in the BNCT conventional neutron transmission code. Because most of the dose absorbed by living cells (65%) comes from the 10B(n,a)7Li response, the distribution of boron determines the variability of the main absorbed dose in the treatment plan. As a result, therapeutic schedule will be improved because the boron distribution will greatly affect the isodose line. Routine calculations provide a wider range of isodose contours, whereas PET produces contours that more closely approximate the observed clinical results of BNCT.
- Conditions
- Solid Tumor, Adult
- Being tested
- BPA-PET imaging
- Keywords
- solid tumor BPA-PET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPA-PET imagingDiagnostic test
PET imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
TBR（Tumor-to-Backgroud Ratio）
We delineate the region of interest (ROI), obtain the maximum standard uptake value (SUVmax) of the ROI in the PET/CT images. The target-to-background ratio (TBR) of the lesion was calculated.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start26 Dec 2022
- Primary completion25 Aug 2023 (estimated)
- Study completion25 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaohua Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaohua Zhu, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538676
- Sponsor's protocol ID
- 2022S150
- Status last verified
- Feb 2023
- First submitted
- 24 Aug 2022
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoride-labeled Boronophenylalanine PET Imaging in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT05538676
- Acronym / sponsor ID
- 2022S150
- Conditions
- Solid Tumor, Adult
- Keywords
- solid tumor BPA-PET
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Xiaohua ZhuUniversity, hospital or other
- Study start
- 26 Dec 2022 (actual)
- Primary completion
- 25 Aug 2023 (estimated)
- Study completion
- 25 Aug 2025 (estimated)
- First posted
- 14 Sep 2022 (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.
Recently, new high-dose radiation therapy [e.g., boron neutron capture therapy (BNCT)] absorbed into the tumor tissue has been applied to treat patients with solid tumors. Here we examine and describe how to evaluate the biological activity of tumors using positron emission tomography (PET) with fluoride-labeled boronophenylalanine (F-BPA) as a tracer.
Detailed description
Boron Neutron Capture Therapy（BNCT） is an advanced cell-scale binary targeted radiotherapy technology that combines the advantages of targeted therapy and heavy ion therapy. BNCT provides a neutron source from a reactor or a medical accelerator. At the same time, the patient needs to be pre-injected with a boron-containing drug containing a non-radioactive boron 10 isotope. The boron drug enters the body and accumulates specifically in cancer cells. The patient receives epithermal neutron beam irradiation with high linear energy transfer (Linear EnergyTransferLET), thereby achieving the effect of killing tumor cells. Purpose，BNCT has more advantages over conventional radiotherapy, and normal tissue is better preserved than conventional radiotherapy.
PET imaging is a useful and effective technique to give absolute quantitative and biological distribution data of BPA in a non-invasive manner, and can add important characteristic parameters such as T/N ratio, SUV and Kinetic parameters. Given the complexity of BNCT, PET and PET/CT is currently the new standard for designing patient recruitment: The Methodology of L-18F-BPA PET is an important tool to design clinical trials , estimate the size of tumor and indicate the concentration ratio of BPA in surrounding normal tissues. Following this principle, researchers can accurately identify which patients can benefit from BNCT treatment through the selective accumulation of BPA in individual tumors. PET scans can provide a three-dimensional map of the boron distribution, which can be used for macroscopic dose calculations in the BNCT conventional neutron transmission code. Because most of the dose absorbed by living cells (65%) comes from the 10B(n,a)7Li response, the distribution of boron determines the variability of the main absorbed dose in the treatment plan. As a result, therapeutic schedule will be improved because the boron distribution will greatly affect the isodose line. Routine calculations provide a wider range of isodose contours, whereas PET produces contours that more closely approximate the observed clinical results of BNCT.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with diagnosed solid tumor
Key inclusion criteria (1 listed)
- patients with clinically diagnosed solid tumors, including but not limited to recurrent head and neck cancer, glioma, pancreatic cancer, osteosarcoma, etc.; The selected subjects need to sign the informed consent.
Key exclusion criteria (1 listed)
- Pregnant women; renal failure (serum Cr>3mg/dl); Patients with claustrophobia;
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 |
|---|---|---|
| BPA-PET imagingPET imaging | Diagnostic test | – |
Primary outcome
TBR（Tumor-to-Backgroud Ratio）
Time frame: 1 year
We delineate the region of interest (ROI), obtain the maximum standard uptake value (SUVmax) of the ROI in the PET/CT images. The target-to-background ratio (TBR) of the lesion was calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- 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?
An observational study of Solid Tumor, Adult, run by Xiaohua Zhu 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 13 Feb 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TBR（Tumor-to-Backgroud Ratio） (time frame: 1 year). 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 13 Feb 2023.