NCT04255628

Brief Summary

Cancer pain deteriorated in quality of life and related with numerous psychosocial problems. Over the one third of cancer patient suffered from moderate to severe cancer pain, even under adequate pain management. The 18F-fluoro-2-deoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) images can provide quantitative results in clinical oncology. As a functional neuroimaging, the PET evidently provided anatomical activated regions, size, and spatial extent information. In this study, we use FDG-PET to investigate changes concerning the glucose metabolism in the brain with or without cancer pain. Therefore, we may provide useful information to treatment target in cancer pain patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
26 days until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2022

Completed
Last Updated

September 21, 2022

Status Verified

January 1, 2022

Enrollment Period

2.1 years

First QC Date

February 3, 2020

Last Update Submit

September 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Brain metabolism change

    The FDG-PET of Standardized uptake values (SUVs) were calculated for each voxel in the reconstructed images to investigate changes concerning the glucose metabolism in the brain with or without cancer pain

    12 months

Study Arms (2)

with cancer pain

head and neck and esophageal cancer patients. with cancer pain

Diagnostic Test: FDG PET

without cancer pain

head and neck and esophageal cancer patients. without cancer pain=30

Diagnostic Test: FDG PET

Interventions

FDG PETDIAGNOSTIC_TEST

Cancer patients who scheduled whole body FDG-PET image scan for clinically indicated.

with cancer painwithout cancer pain

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Sixty patients in each group of head and neck and esophageal cancer patients. Each cancer group include without cancer pain=30, with cancer pain=30.

You may qualify if:

  • Cancer patients who scheduled whole body FDG-PET image scan for clinically indicated.
  • Age \> 20

You may not qualify if:

  • Unable to complete questionnaires.
  • Prior evidence of brain metastases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hosipital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2020

First Posted

February 5, 2020

Study Start

March 2, 2020

Primary Completion

March 28, 2022

Study Completion

December 29, 2022

Last Updated

September 21, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations