Breast CancerNCT01254591
Positron Emission Tomography/Computed Tomography Scanning Before Surgery in Patients With Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer, Esophageal Cancer, or Head and Neck Cancer
A study testing 18F-fluoromisonidazole, fluorescence angiography and laboratory biomarker analysis in people with Breast Cancer and Colorectal Cancer, run by University College London (UCL) Cancer Institute at 1 site in United Kingdom.
Trial summary
RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease. PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Esophageal Cancer
- What is being tested?
- 18F-fluoromisonidazole, fluorescence angiography and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2006to Aug 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer
- Potentially operable disease
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Not specified
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College Hospital
London, England, NW1 2BU
Contact Person, 44-207-631-1066, peter.ell@uclh.nhs.uk
About this study
Official title: Tumor Angiogenesis in Non-Small Cell Lung (NSCLC), Colorectal, Breast, Esophageal, Head and Neck Cancer: Radiology-Pathology and Prognostic Correlation
RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease.
PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.
Read the detailed description
OBJECTIVES:
- To determine the ability of preoperative fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning in assessing tumor angiogenesis in patients with potentially operable non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.
- To determine the ability of preoperative fludeoxyglucose F 18 PET/CT scanning in assessing prognosis by means of measuring angiogenesis in these patients.
OUTLINE: All patients undergo fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning for staging, tumor perfusion measurement/angiogenesis, and glucose metabolism. If staging confirms operable disease, then the patient proceeds to surgery as planned. Resected tumor tissue samples are examined for tumor angiogenesis in the various cancer types.
Some patients undergo a half-dose of rubidium Rb-82 or 18F-fluoromisonidazole or [18F]-ML-10 PET scan or fluorescence angiography. Patients with colorectal cancer undergo a CT scan for perfusion of the tumor after the staging PET/CT. Patients with breast cancer undergo infrared thermometry as well as a MRI scan for staging and to predict angiogenesis.
After completion of study therapy, patients are followed up at 1 month and then every 6 months for 5 years.
- Being tested
- 18F-fluoromisonidazole, fluorescence angiography, laboratory biomarker analysis, infrared thermography, magnetic resonance imaging
- Keywords
- stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage I colon cancer, stage IIA colon cancer, stage IIB colon cancer, stage IIC colon cancer, stage IIIA colon cancer, stage I rectal cancer, stage IIA rectal cancer, stage IIB rectal cancer, stage IIC rectal cancer, stage IIIA rectal cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Head and Neck Neoplasms, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluoromisonidazoleOther
fluorescence angiographyOther
laboratory biomarker analysisOther
infrared thermographyProcedure or surgery
magnetic resonance imagingProcedure or surgery
therapeutic conventional surgeryProcedure or surgery
[18F]-ML-10Radiation
fludeoxyglucose F 18Radiation
rubidium Rb-82Radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical, radiological, and pathological correlation
Prognosis (6-month, 1-year, 3-year, and 5-year mortality including local/distance recurrence rates)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2010 (estimated)
- Study startNov 2006
- Primary completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London (UCL) Cancer Institute
- Sponsor type
- University, hospital or other
- Investigators
- Peter Ell, MD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254591
- Sponsor's protocol ID
- CDR0000689973
- Other IDs
- UCL-TUMOR-ANGIOGENESIS, EU-21086
- Status last verified
- Dec 2010
- First submitted
- 3 Dec 2010
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Angiogenesis in Non-Small Cell Lung (NSCLC), Colorectal, Breast, Esophageal, Head and Neck Cancer: Radiology-Pathology and Prognostic Correlation
- ClinicalTrials.gov ID
- NCT01254591
- Acronym / sponsor ID
- CDR0000689973
- Keywords
- stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage I colon cancer, stage IIA colon cancer, stage IIB colon cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University College London (UCL) Cancer InstituteUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Aug 2013 (estimated)
- First posted
- 6 Dec 2010 (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.
RATIONALE: Diagnostic procedures, such as positron emission tomography/computed tomography (PET/CT) scanning before surgery, may help measure the extent of disease.
PURPOSE: This clinical trial is studying PET/CT scanning before surgery in patients with non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.
Detailed description
OBJECTIVES:
- To determine the ability of preoperative fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning in assessing tumor angiogenesis in patients with potentially operable non-small cell lung cancer, colorectal cancer, breast cancer, esophageal cancer, or head and neck cancer.
- To determine the ability of preoperative fludeoxyglucose F 18 PET/CT scanning in assessing prognosis by means of measuring angiogenesis in these patients.
OUTLINE: All patients undergo fludeoxyglucose F 18 positron emission tomography/computed tomography (PET/CT) scanning for staging, tumor perfusion measurement/angiogenesis, and glucose metabolism. If staging confirms operable disease, then the patient proceeds to surgery as planned. Resected tumor tissue samples are examined for tumor angiogenesis in the various cancer types.
Some patients undergo a half-dose of rubidium Rb-82 or 18F-fluoromisonidazole or [18F]-ML-10 PET scan or fluorescence angiography. Patients with colorectal cancer undergo a CT scan for perfusion of the tumor after the staging PET/CT. Patients with breast cancer undergo infrared thermometry as well as a MRI scan for staging and to predict angiogenesis.
After completion of study therapy, patients are followed up at 1 month and then every 6 months for 5 years.
Study design
- Primary purpose
- Diagnosis
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| 18F-fluoromisonidazole | Other | – |
| fluorescence angiography | Other | – |
| laboratory biomarker analysis | Other | – |
| infrared thermography | Procedure or surgery | – |
| magnetic resonance imaging | Procedure or surgery | – |
| therapeutic conventional surgery | Procedure or surgery | – |
| [18F]-ML-10 | Radiation | – |
| fludeoxyglucose F 18 | Radiation | – |
| rubidium Rb-82 | Radiation | – |
Primary outcome
Clinical, radiological, and pathological correlation
Prognosis (6-month, 1-year, 3-year, and 5-year mortality including local/distance recurrence rates)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
Peter Ell, MD principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-fluoromisonidazole, fluorescence angiography and laboratory biomarker analysis in people with Breast Cancer and Colorectal Cancer, run by University College London (UCL) Cancer Institute at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2013. 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 Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical, radiological, and pathological correlation. 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 26 Aug 2013.