NCT06433817

Brief Summary

The purpose of this study was to explore the potential application of spectral CT for radiotherapy in cervical cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
May 2024Dec 2026

First Submitted

Initial submission to the registry

May 8, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

May 22, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 30, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

May 8, 2024

Last Update Submit

May 27, 2024

Conditions

Cervical CancerRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

    through study completion, an average of 2 year

Secondary Outcomes (2)

  • Identifying metastatic lymph nodes in cervical cancer with spectral CT

    through study completion, an average of 2 year

  • Application of energy spectrum CT in brachytherapy of cervical cancer

    through study completion, an average of 2 year

Interventions

Spectral computed tomography scanRADIATION

Spectral CT scans acquisition performed during the arterial phase and venous phase for cervical cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients with newly stablished diagnosis of cervical cancer complying with selection criteria for cervical cancer.

You may qualify if:

  • 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

You may not qualify if:

  • CT without spectral scans
  • History of allergy to intravenous contrast
  • Pregnant or potentially pregnant female subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Fuquan Zhang, Porf

CONTACT

86 01069154072zhangfq@pumch.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2024

First Posted

May 30, 2024

Study Start

May 22, 2024

Primary Completion (Estimated)

May 22, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)