Cervical CancerNCT06433817
Spectral CT in Radiotherapy for Cervical Cancer
An observational study of Cervical Cancer and Radiotherapy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study was to explore the potential application of spectral CT for radiotherapy in cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Radiotherapy
- What is being tested?
- Spectral computed tomography scan
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2024to 31 Dec 2026
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: adult patients with newly stablished diagnosis of cervical cancer complying with selection criteria for cervical cancer.
Who may be able to join
- All patients were confirmed cervical cancer by pathology
- patients were treated with concurrent chemoradiotherapy
- Spectral CT scans acquisition performed during the arterial phase and venous phase
- All the patients underwent a 18F-FDG PET/CT before treatment
Who cannot join
- CT without spectral scans
- History of allergy to intravenous contrast
- Pregnant or potentially pregnant female subjects
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, 100010
Zheng Zeng, MD., 86 01069154073, zengzheng1206@163.com
About this study
Official title: The Clinical Research of Spectral CT in Radiotherapy for Cervical Cancer
The purpose of this study was to explore the potential application of spectral CT for radiotherapy in cervical cancer.
- Conditions
- Cervical Cancer, Radiotherapy
- Being tested
- Spectral computed tomography scan
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectral computed tomography scanRadiation
Spectral CT scans acquisition performed during the arterial phase and venous phase for cervical cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of spectral CT derived data with response evaluation in cervical cancer
To evaluate the tumor response of using quantitative parameters in spectral CT for cervical cancer patients according to RECIST 1.1
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
Identifying metastatic lymph nodes in cervical cancer with spectral CT
To evaluate the diagnostic performances of using spectral CT for identifying metastatic lymph nodes in patients with cervical cancer
Measured: through study completion, an average of 2 year
Application of energy spectrum CT in brachytherapy of cervical cancer
The ability to reduce metal artifact and assist in target delineation
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start22 May 2024 (estimated)
- Primary completion22 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 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
- NCT06433817
- Sponsor's protocol ID
- SPRTCC-Trial
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of Spectral CT in Radiotherapy for Cervical Cancer
- ClinicalTrials.gov ID
- NCT06433817
- Acronym / sponsor ID
- SPRTCC-Trial
- Conditions
- Cervical Cancer, Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 22 May 2024 (estimated)
- Primary completion
- 22 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 May 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 purpose of this study was to explore the potential application of spectral CT for radiotherapy in cervical cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with newly stablished diagnosis of cervical cancer complying with selection criteria for cervical cancer.
Key inclusion criteria (4 listed)
- All patients were confirmed cervical cancer by pathology
- patients were treated with concurrent chemoradiotherapy
- Spectral CT scans acquisition performed during the arterial phase and venous phase
- All the patients underwent a 18F-FDG PET/CT before treatment
Key exclusion criteria (3 listed)
- CT without spectral scans
- History of allergy to intravenous contrast
- Pregnant or potentially pregnant female subjects
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 computed tomography scanSpectral CT scans acquisition performed during the arterial phase and venous phase for cervical cancer | Radiation | – |
Primary outcome
Comparison of spectral CT derived data with response evaluation in cervical cancer
Time frame: through study completion, an average of 2 year
To evaluate the tumor response of using quantitative parameters in spectral CT for cervical cancer patients according to RECIST 1.1
2 secondary outcomes
Identifying metastatic lymph nodes in cervical cancer with spectral CT
Time frame: through study completion, an average of 2 year
Application of energy spectrum CT in brachytherapy of cervical cancer
Time frame: through study completion, an average of 2 year
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 30 May 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?
An observational study of Cervical Cancer and Radiotherapy, 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 4 inclusion and 3 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 30 May 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 Fuquan Zhang, Porf (86 01069154072, zhangfq@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of spectral CT derived data with response evaluation in cervical cancer (time frame: through study completion, an average of 2 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 30 May 2024.