Pancreatic AdenocarcinomaGCC 1210NCT01764659

4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

An observational study of Pancreatic Adenocarcinoma, run by University of Maryland, Baltimore at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pancreatic Adenocarcinoma
What is being tested?: Contrast-enhanced 4D computed tomography
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Jul 2013to Oct 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
No healthy volunteers
Adult, Older adult

Study population: GI/GU multi-d clinic

Who may be able to join

Patients 18 years old or older
Patients with PDA who have not had surgical removal of their tumor and who are planned for treatment with radiotherapy in the Radiation Oncology Department at the University of Maryland.
Patients who have signed the contrast consent form and have been recommended by physicians to have contrast-enhanced CT scans.
Patients who have signed the consent form for this study

Who cannot join

Pregnant or breast-feeding women.
Patients with severely decreased renal function19-21.
Patients with known severe allergic reactions to contrast.
Patients who have difficulty lying flat on their back for extended periods of time.
Patients with breaths per minute (BPM) rate less than 10, due to the limitation of 4D-CT image reconstruction software.

Trial locations and contacts

1 site in 1 country.

United States1 site

Ummc Msgcc
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Individually Optimized Contrast-Enhancement 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation

The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.

Read the detailed description

Compared with current clinical practice, the individually optimized CE 4D-CT can potentially provide much improved tumor-to-parenchyma conspicuity of pancreatic adenocarcinoma. This will help the radiation oncologists or radiologists to contour the tumor with higher precision and confidence, and compute the tumor volume and tumor motion more accurately.

Conditions: Pancreatic Adenocarcinoma
Being tested: Contrast-enhanced 4D computed tomography
Keywords: 4D-CT, Contrast Enhanced CT, Radiotherapy Simulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Contrast-enhanced 4D computed tomographyOther
All enrolled patients each underwent three CT scans: a 4DCT immediately following a contrast-enhanced 3DCT and an individually optimized contrast-enhanced 4DCT.

Study groups in NCT01764659
Study group	Role	What they receive
All enrolled patients		Contrast-enhanced 4D computed tomography Receives: Other: Contrast-enhanced 4D computed tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation
Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2013Oct 2014

First posted9 Jan 2013 (estimated)
Study startJul 2013
Primary completionOct 2014
Study completionOct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
More trials run by University of Maryland, BaltimoreThe 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: Case only
Time perspective: Prospective
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01764659
Sponsor's protocol ID: HP-00052534
Acronym: GCC 1210
Status last verified: Mar 2020
First submitted: 2 Jan 2013
Last updated: 27 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Individually Optimized Contrast-Enhancement 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation
ClinicalTrials.gov ID: NCT01764659
Acronym / sponsor ID: GCC 1210 / HP-00052534
Conditions: Pancreatic Adenocarcinoma
Keywords: 4D-CT, Contrast Enhanced CT, Radiotherapy Simulation
Study type: Observational
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: University of Maryland, BaltimoreUniversity, hospital or other
Study start: Jul 2013
Primary completion: Oct 2014 (actual)
Study completion: Oct 2014 (actual)
First posted: 9 Jan 2013 (estimated)
Results: Posted 27 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All enrolled patients	–	Other: Contrast-enhanced 4D computed tomographyContrast-enhanced 4D computed tomography

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: GI/GU multi-d clinic

Key inclusion criteria (4 listed)

Patients 18 years old or older
Patients with PDA who have not had surgical removal of their tumor and who are planned for treatment with radiotherapy in the Radiation Oncology Department at the University of Maryland.
Patients who have signed the contrast consent form and have been recommended by physicians to have contrast-enhanced CT scans.
Patients who have signed the consent form for this study

Key exclusion criteria (5 listed)

Pregnant or breast-feeding women.
Patients with severely decreased renal function19-21.
Patients with known severe allergic reactions to contrast.
Patients who have difficulty lying flat on their back for extended periods of time.
Patients with breaths per minute (BPM) rate less than 10, due to the limitation of 4D-CT image reconstruction software.

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
Contrast-enhanced 4D computed tomographyAll enrolled patients each underwent three CT scans: a 4DCT immediately following a contrast-enhanced 3DCT and an individually optimized contrast-enhanced 4DCT.	Other	All enrolled patients

Primary outcome

Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation
Time frame: 1 year
Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.

Results and safety

Results posted to the registry on 27 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Patients	14	12

Primary outcome: Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation

Time frame: 1 year. Mean (Standard Deviation). Unit: units on a scale

Measure	CE 3DCT n = 10	4DCT n = 10	CE 4DCT n = 10
Anatomic details	4.1 (0.8)	2.5 (0.6)	3.6 (0.8)
Motion artifacts	3.9 (1.0)	3.4 (0.9)	3.7 (0.8)
Beam hardening	4.2 (0.8)	3.3 (0.9)	3.5 (0.8)
Enhancement of pancreatic tissue and tumor	3.2 (1.0)	1.7 (0.9)	3.3 (1.0)

Population analysed: Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.

Primary outcome: Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation

Time frame: 1 year. Mean (Standard Deviation). Unit: HU

Measure	CE 3DCT n = 10	4DCT n = 10	CE 4DCT n = 10
Pancreas CT number (HU)	49.2 (12.3)	44.6 (15.9)	75.5 (21.2)
Tumor CT number (HU)	53.0 (9.2)	58.9 (14.3)	76.3 (15.0)
Tumor to pancreas contrast (HU)	15.5 (20.7)	9.2 (9.2)	16.7 (12.3)
Noise (HU)	12.5 (3.9)	19.4 (5.8)	22.1 (5.7)

Population analysed: Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.

Primary outcome: Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation

Time frame: 1 year. Mean (Standard Deviation). Unit: contrast to noise ratio

Measure	CE 3DCT n = 10	4DCT n = 10	CE 4DCT n = 10
Value	1.4 (1.9)	0.6 (0.7)	0.8 (0.6)

Population analysed: Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Patients	0 of 14 (0%)	0 of 14 (0%)	1 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
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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.

Wei Lu, Ph. D., DABR principal investigator

UMMC MSGCC

Hao H Zhang, Ph. D. principal investigator

UMMC

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 Pancreatic Adenocarcinoma, run by University of Maryland, Baltimore at 1 site in United States.

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: finished, as of the sponsor's last update on 27 Mar 2020. 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 United States. 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?

Yes. Results are posted in the registry (first posted 27 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01764659.

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 27 Mar 2020.