Metastatic Malignant Neoplasm in the LiverNCT00862680
4D PET/CT in Diagnosing Participants With Lung and Colorectal Cancer With Liver and Lung Metastasis
An observational study of Metastatic Malignant Neoplasm in the Liver and Metastatic Malignant Neoplasm in the Lung, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This trial studies how well 4 dimensional (D) positron emission tomography/computed tomography (PET/CT) works in diagnosing participants with lung or colorectal cancer that has spread to the liver and lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung, Stage IV Colorectal Cancer AJCC v8
- What is being tested?
- 4-Dimensional Computed Tomography and 4D PET Scan
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2009to 28 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients with suspected colorectal cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.
- Patients with suspected lung cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.
Who cannot join
- Patients that cannot tolerate being scanned for an additional 12 minutes with arms above their head will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 4D PET/CT Imaging in Lung and Colorectal Cancer With Liver Metastasis
This trial studies how well 4 dimensional (D) positron emission tomography/computed tomography (PET/CT) works in diagnosing participants with lung or colorectal cancer that has spread to the liver and lung. Diagnostic procedures, such as PET/CT, may help find and diagnose disease and find out how far the disease has spread. But the motions made by breathing can reduce the image quality of the scan. Adjusting the scanner to 4D may allow for more breathing motion may improve the quality of the PET/CT images.
Read the detailed description
PRIMARY OBJECTIVES:
- Study the impact of 4D positron emission tomography/computed tomography (PET/CT) imaging on the evaluation and staging of lung and colorectal cancer.
OUTLINE:
Participants undergo 4D PET/CT scan over up to 12 minutes.
- Conditions
- Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8
- Being tested
- 4-Dimensional Computed Tomography, 4D PET Scan
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-Dimensional Computed TomographyProcedure or surgery
Also called 4D Computed Tomography, 4DCT, Time-Resolved CT Data Acquisition
Undergo 4D PET/CT
4D PET ScanProcedure or surgery
Also called 4D Gated PET, 4D Gated PET Scan, 4D PET
Undergo 4D PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (4D PET/CT) | Participants undergo 4D PET/CT scan over up to 12 minutes. Receives: Procedure: 4-Dimensional Computed Tomography; Procedure: 4D PET Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum lesion standardized uptake value (SUVmax) for gated and ungated positron emission tomography/computed tomography (PET/CT) scans
Will be compared using a one-sided paired t-test.
Measured: Up to 10 years
Impact of the difference in SUVmax on the lesion detectability and staging of the evaluated patients
two nuclear medicine physicians will assess the impact of the difference in SUVmax on the lesion detectablility and staging of the evaluated patients.
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study start12 Mar 2009
- Primary completion28 Apr 2019
- Study completion28 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant Neoplasm in the LiverStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Other
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Osama Mawlawi, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862680
- Sponsor's protocol ID
- 2008-0853
- Other IDs
- NCI-2018-01858, 2008-0853, P30CA016672
- Status last verified
- Apr 2020
- First submitted
- 16 Mar 2009
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4D PET/CT Imaging in Lung and Colorectal Cancer With Liver Metastasis
- ClinicalTrials.gov ID
- NCT00862680
- Acronym / sponsor ID
- 2008-0853
- Conditions
- Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung, Stage IV Colorectal Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Colorectal Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 12 Mar 2009 (actual)
- Primary completion
- 28 Apr 2019 (actual)
- Study completion
- 28 Apr 2019 (actual)
- First posted
- 17 Mar 2009 (estimated)
- 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.
This trial studies how well 4 dimensional (D) positron emission tomography/computed tomography (PET/CT) works in diagnosing participants with lung or colorectal cancer that has spread to the liver and lung. Diagnostic procedures, such as PET/CT, may help find and diagnose disease and find out how far the disease has spread. But the motions made by breathing can reduce the image quality of the scan. Adjusting the scanner to 4D may allow for more breathing motion may improve the quality of the PET/CT images.
Detailed description
PRIMARY OBJECTIVES:
- Study the impact of 4D positron emission tomography/computed tomography (PET/CT) imaging on the evaluation and staging of lung and colorectal cancer.
OUTLINE:
Participants undergo 4D PET/CT scan over up to 12 minutes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (4D PET/CT) | – | Procedure: 4-Dimensional Computed Tomography, Procedure: 4D PET ScanParticipants undergo 4D PET/CT scan over up to 12 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with suspected colorectal cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.
- Patients with suspected lung cancer with nodules in the lung or liver (1-2 cm in diameter) will be eligible for this study.
Key exclusion criteria (1 listed)
- Patients that cannot tolerate being scanned for an additional 12 minutes with arms above their head will be excluded.
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 |
|---|---|---|
| 4-Dimensional Computed TomographyAlso: 4D Computed Tomography, 4DCT, Time-Resolved CT Data AcquisitionUndergo 4D PET/CT | Procedure or surgery | Diagnostic (4D PET/CT) |
| 4D PET ScanAlso: 4D Gated PET, 4D Gated PET Scan, 4D PETUndergo 4D PET/CT scan | Procedure or surgery | Diagnostic (4D PET/CT) |
Primary outcome
Maximum lesion standardized uptake value (SUVmax) for gated and ungated positron emission tomography/computed tomography (PET/CT) scans
Time frame: Up to 10 years
Will be compared using a one-sided paired t-test.
Impact of the difference in SUVmax on the lesion detectability and staging of the evaluated patients
Time frame: Up to 10 years
two nuclear medicine physicians will assess the impact of the difference in SUVmax on the lesion detectablility and staging of the evaluated patients.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Osama Mawlawi principal investigator
M.D. Anderson Cancer Center
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 Metastatic Malignant Neoplasm in the Liver and Metastatic Malignant Neoplasm in the Lung, run by M.D. Anderson Cancer Center 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 2 inclusion and 1 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 14 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum lesion standardized uptake value (SUVmax) for gated and ungated positron emission tomography/computed tomography (PET/CT) scans (time frame: Up to 10 years). The study lists 2 primary outcomes in all. 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 14 Apr 2020.