NCT02592304

Brief Summary

Endpoints subproject 1: To develop a reproducible method for the detection of lymph nodes by DECT in operation specimens from rectal resection for cancer. sub project 2: Primary endpoint: To evaluate the sensitivity and specificity for malignant lymph nodes in vitro RC specimens compared with histopathology. Secondary endpoint: To assess DECT as imaging tool for the diagnosis of malignant lymph nodes at RC. Histopathology will be used as reference.Subproject 3: Primary endpoint: To compare the sensitivity, specificity, positive- and negative predictive values, accuracy of DECT and standard MRI. Secondary: To evaluate the value of the gold standard for the use of imaging methods for the description of the lymph node, validated by histopathology. Secondary: to determine the value of tumor diagnostics using DECT.subproject 4: To assess the value of DECT as imaging tool for diagnosing response to chemo radiotherapy of malignant lymph nodes.

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
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

October 7, 2015

Last Update Submit

October 29, 2015

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (4)

  • the detection of lymph nodes by DECT in specimens from rectal resection for cancer.

    Measurments will be done in Hounsfield units, effective z-value and iodine, water and gadolinium concentrations.

    6 months

  • sensitivity and specificity for the detection of malignant lymph nodes in vitro RC specimens compared with histopathology

    Measurments will be done in Hounsfield units, effective z-value and iodine, water and gadolinium concentrations.

    6 months

  • sensitivity, specificity, positive- ognegative predictive values, accuracy of DECT and standard MRI.

    Measurments will be done in Hounsfield units, effective z-value and iodine, water and gadolinium concentrations. Histopathological proved malignant lymph nodes will be compared to histopathological proved benign lymph nodes.

    1 year

  • DECT as imaging tool for diagnosing response to chemo radiotherapy of malignant lymph nodes, and tumors.

    Rectal Cancer Regression Grade (RCRG) according to the three levels RCRG 1-3. RCRG 1: the tumour is either sterilised or only microscopic foci of adenocarcinoma remain; RCRG 2: marked fibrosis, but with macroscopic tumour still present; and RCRG 3: little or no fibrosis in the presence of abundant macroscopic tumour , based on measurments of Hounsfield units, effective z-value and iodine, water and gadolinium concentrations.

    1 year

Study Arms (1)

dual energy ct

OTHER
Device: Dual energy computed tomography

Interventions

Dual energy computed tomographyDEVICE

one extra scanning with a dual energy ct.

dual energy ct

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- All patients with an endoscopic suspected rectal cancer.

You may not qualify if:

  • Chronic kidney failure
  • pregnancy
  • rectal cancer recurrence
  • known contrast allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Issam al-Najami

Svendborg, Southern Denmark, 5700, Denmark

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 7, 2015

First Posted

October 30, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2017

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

DK(1)