Adult ALLNCT05361356
Spectral CT Clinical Trial
A study testing Spectral CT scanning in people with Adult ALL, run by Philips (China) Investment CO., LTD at 3 sites in China.
Trial summary
The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult ALL
- What is being tested?
- Spectral CT scanning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 3 sitesChina
- Study dates
- 10 Mar 2022to 27 Feb 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers (ages 18 to 75);
- Negative pregnancy tests for women of childbearing age;
- Agree to participate in the clinical trial and sign the subject informed consent form;
- Enhanced scan requires laboratory evidence of normal renal function.
Who cannot join
- The body cannot comply with CT examination;
- Pregnant and lactating women;
- Claustrophobia;
- People who are not suitable for enhanced scanning with iodine contrast agent (previous severe heart failure and hyperthyroidism, iodine contrast agent allergy and susceptibility);
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking Union Medical College Hospital
Beijing
Nanfang Hospital
Guangzhou
The First Hospital of Xian Jiaotong University
Xi'an
About this study
The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.
Read the detailed description
Under the premise of protecting subjects and ensuring the scientific nature of this clinical trial, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.
- Conditions
- Adult ALL
- Being tested
- Spectral CT scanning
- Keywords
- CT scanning, image assessment
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral CT scanningRadiation
Volunteer accept spectral CT scanning
| Study group | Role | What they receive |
|---|---|---|
| Experimental group, all volunteer will be scanned. | Experimental | All participation accept Spectral CT scanning; No group; Receives: Radiation: Spectral CT scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent and good rate of clinical imaging (score≥3）
Rated items 5 points Excellent image quality for diagnostic purposes, very satisfactory 4 points good image quality, can be used for diagnosis, satisfactory 3 points Image quality defects, do not affect the diagnosis, general 2. Unsatisfactory image quality, affecting diagnosis Poor image quality, undiagnosable, unsatisfactory
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Common functions assessment
Common function evaluation items inclduing:The exposure function; Bed body moving; Microphone intercom function; Image post-processing function; Data storage management. With Satisfied, normal, Not Satisfied
Measured: through study completion, an average of 1 year
Convenience evaluation assessment
Convenience function evaluation items inclduing:Laser positioning lamp Breathing navigation Control buttons The clinical interface friendliness of postprocessing software The post-processing software is convenient for clinical use and operation. With Satisfied, normal, Not Satisfied
Measured: through study completion, an average of 1 year
Machine function and stability assessment
Machine function and stability evaluation items inclduing:workflow Image display and transmission Failed to start system Unexpected system shutdown Abnormal termination during the scan Unable to expose during scan. With Satisfied, normal, Not Satisfied
Measured: through study completion, an average of 1 year
Adverse events and serious adverse events
Adverse events and serious adverse events during the test were collected to evaluate the safety of the product.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start10 Mar 2022
- Primary completion19 Oct 2022
- Study completion27 Feb 2023
Why it stopped: Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ALLStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips (China) Investment CO., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daming Zhang, Study director, Peking Union Medical College HospitalYikai Xu, Principal investigator, Nanfang Hospital, Southern Medical UniversityTing Liu, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361356
- Sponsor's protocol ID
- PD_CT_Hawk_2021_11257
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2022
- Last updated
- 7 Apr 2023
- 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 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral CT Clinical Trial
- ClinicalTrials.gov ID
- NCT05361356
- Acronym / sponsor ID
- PD_CT_Hawk_2021_11257
- Conditions
- Adult ALL
- Keywords
- CT scanning, image assessment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Philips (China) Investment CO., LTDIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 4 May 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.
The objective of this clinical trial was to evaluate the efficacy, ease of operation, stability, and safety of Spectral CT as expected.
Detailed description
Under the premise of protecting subjects and ensuring the scientific nature of this clinical trial, Spectral CT was evaluated for its effectiveness, convenience, stability and safety under normal conditions by collecting clinical cases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group, all volunteer will be scanned. | Experimental | Radiation: Spectral CT scanningAll participation accept Spectral CT scanning; No group; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteers (ages 18 to 75);
- Negative pregnancy tests for women of childbearing age;
- Agree to participate in the clinical trial and sign the subject informed consent form;
- Enhanced scan requires laboratory evidence of normal renal function.
Key exclusion criteria (5 listed)
- The body cannot comply with CT examination;
- Pregnant and lactating women;
- Claustrophobia;
- People who are not suitable for enhanced scanning with iodine contrast agent (previous severe heart failure and hyperthyroidism, iodine contrast agent allergy and susceptibility);
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
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 |
|---|---|---|
| Spectral CT scanningVolunteer accept spectral CT scanning | Radiation | Experimental group, all volunteer will be scanned. |
Primary outcome
Excellent and good rate of clinical imaging (score≥3）
Time frame: through study completion, an average of 1 year
Rated items 5 points Excellent image quality for diagnostic purposes, very satisfactory 4 points good image quality, can be used for diagnosis, satisfactory 3 points Image quality defects, do not affect the diagnosis, general 2. Unsatisfactory image quality, affecting diagnosis Poor image quality, undiagnosable, unsatisfactory
4 secondary outcomes
Common functions assessment
Time frame: through study completion, an average of 1 year
Convenience evaluation assessment
Time frame: through study completion, an average of 1 year
Machine function and stability assessment
Time frame: through study completion, an average of 1 year
Adverse events and serious adverse events
Time frame: through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- 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. This study is not recruiting at the moment.
Daming Zhang study director
Peking Union Medical College Hospital
Yikai Xu principal investigator
Nanfang Hospital, Southern Medical University
Ting Liu study director
First Affiliated Hospital Xi'an Jiaotong University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectral CT scanning in people with Adult ALL, run by Philips (China) Investment CO., LTD at 3 sites 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was stopped early (reason given: Investigational product had been released in NMPA, Sponsor decided to terminate the study aligned with investigator.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent and good rate of clinical imaging (score≥3） (time frame: through study completion, an average of 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 7 Apr 2023.