Squamous Cell CarcinomaNCT01020097
Fluorine F 18 EF5 Positron Emission Tomography in Assessing Hypoxia in Patients With Newly Diagnosed Stage I, Stage II, Stage III, or Stage IV Head or Neck Squamous Cell Cancer of the Oral Cavity, Oropharynx, and Larynx
A study testing fluorine F18 EF5, immunohistochemistry staining method and biopsy in people with Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Rationale: Diagnostic procedures, such as positron emission tomography, using the drug fluorine F 18-EF5 to find oxygen in tumor cells may help in planning cancer treatment. Purpose: This clinical trial studies fluorine F 18-EF5 positron emission tomography in assessing hypoxia in patients with newly diagnosed stage… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- fluorine F18 EF5, immunohistochemistry staining method and biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a histologically confirmed and/or clinical and imaging evidence of a Stage 1-4 de novo mass in the larynx, pharynx or oral cavity
- Treatment plan should include Surgery (Biopsy or Excision) and may be followed by radiation and/ or concurrent chemotherapy
- Patients' disease must not require emergency surgical attention
- The need for tracheotomy and/or feeding tube placement preceding definitive surgery is not a contradiction for participation
- Patients must have a Karnofsky performance status >= 70
- Patients must have a clinical condition and physiologic status for which the standard initial therapy is surgical biopsy or resection
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- Patients must have normal organ and marrow function as defined below:
- WBC > 2,000/mm^3
- Platelets > 100,000/mm^3
- Total bilirubin
- Creatinine
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation (1 month)
- Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- Serum pregnancy testing will be required for women of childbearing age
- Ability to understand and the willingness to sign a written informed consent
Who cannot join
- History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women and women who are breastfeeding
- Patients whose clinical status requires that surgery for their HNSCC be performed emergently or in a time course that does not allow scheduling of an 18F-EF5 PET scan preceding surgery and chemoradiation
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?
Rationale: Diagnostic procedures, such as positron emission tomography, using the drug fluorine F 18-EF5 to find oxygen in tumor cells may help in planning cancer treatment.
Purpose: This clinical trial studies fluorine F 18-EF5 positron emission tomography in assessing hypoxia in patients with newly diagnosed stage I, stage II, stage III, or stage IV squamous cell cancer of the oral cavity, oropharynx, and larynx.
Read the detailed description
Detailed DescriptionPRIMARY OBJECTIVES:
- Describe the patterns and levels of 18F-EF5 in Stage 1 - 4 de novo HNSCC of the oral cavity, oropharynx and larynx.
II. Determine whether the 18F-EF5 PET images are predictive of patient outcome (event-free survival; EFS and overall survival; OS).
III. Determine whether any statistically significant prognostic relationships found in the corresponding grant are independent of nodal status.
SECONDARY OBJECTIVES:
- Explore the relationship between 18F-EF5 signal and other measures of hypoxia (serum OPN; HIF1alpha protein expression), proliferation (Ki67+ cells/high power field (HPF)), apoptosis and radiation resistance (pAkt expression).
OUTLINE:
Patients undergo fluorine F 18-EF5 positron emission tomography imaging. Scans are performed 180 minutes following injection.
After completion of study, patients are followed at 2-4 weeks and 4-6 weeks.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- fluorine F18 EF5, immunohistochemistry staining method, biopsy, Positron Emission tomography
- Keywords
- Stage 1 squamous cell carcinoma of the larynx
- Medical subject headings
- Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorine F18 EF5Drug
Also called 18F-EF5
Given IV
immunohistochemistry staining methodProcedure or surgery
Also called immunohistochemistry
Correlative study
biopsyProcedure or surgery
Also called biopsies
Correlative study
Positron Emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo scan
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Other | Patients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection. Receives: Drug: fluorine F18 EF5; Procedure: immunohistochemistry staining method; Procedure: biopsy; Procedure: Positron Emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-EF5 standardized uptake values (SUV)
Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.
Measured: Study completion
Tumor to normal tissue (T:N) ratios
Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.
Measured: Study completion
Secondary outcomes (1)
Event-free survival and overall survival
Length of time from end of treatment to recurrence or death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01020097
- Sponsor's protocol ID
- UPCC 17308
- Status last verified
- Apr 2020
- First submitted
- 18 Nov 2009
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is 18F-EF5 PET Imaging Useful in Determining the Prognosis of Newly Diagnosed Head and Neck Squamous Cell Carcinoma?
- ClinicalTrials.gov ID
- NCT01020097
- Acronym / sponsor ID
- UPCC 17308
- Conditions
- Squamous Cell Carcinoma
- Keywords
- Stage 1 squamous cell carcinoma of the larynx
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Nov 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.
Rationale: Diagnostic procedures, such as positron emission tomography, using the drug fluorine F 18-EF5 to find oxygen in tumor cells may help in planning cancer treatment.
Purpose: This clinical trial studies fluorine F 18-EF5 positron emission tomography in assessing hypoxia in patients with newly diagnosed stage I, stage II, stage III, or stage IV squamous cell cancer of the oral cavity, oropharynx, and larynx.
Detailed description
Detailed DescriptionPRIMARY OBJECTIVES:
- Describe the patterns and levels of 18F-EF5 in Stage 1 - 4 de novo HNSCC of the oral cavity, oropharynx and larynx.
II. Determine whether the 18F-EF5 PET images are predictive of patient outcome (event-free survival; EFS and overall survival; OS).
III. Determine whether any statistically significant prognostic relationships found in the corresponding grant are independent of nodal status.
SECONDARY OBJECTIVES:
- Explore the relationship between 18F-EF5 signal and other measures of hypoxia (serum OPN; HIF1alpha protein expression), proliferation (Ki67+ cells/high power field (HPF)), apoptosis and radiation resistance (pAkt expression).
OUTLINE:
Patients undergo fluorine F 18-EF5 positron emission tomography imaging. Scans are performed 180 minutes following injection.
After completion of study, patients are followed at 2-4 weeks and 4-6 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Other | Drug: fluorine F18 EF5, Procedure: immunohistochemistry staining method, Procedure: biopsy, Procedure: Positron Emission tomographyPatients undergo fluorine F-18 EF5 positron emission tomography imaging. Scana are performed 180 minutes following injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients must have a histologically confirmed and/or clinical and imaging evidence of a Stage 1-4 de novo mass in the larynx, pharynx or oral cavity
- Treatment plan should include Surgery (Biopsy or Excision) and may be followed by radiation and/ or concurrent chemotherapy
- Patients' disease must not require emergency surgical attention
- The need for tracheotomy and/or feeding tube placement preceding definitive surgery is not a contradiction for participation
- Patients must have a Karnofsky performance status >= 70
Key exclusion criteria (4 listed)
- History of allergic reactions attributed to Flagyl (metronidazole), which has a chemical structure similar to EF5
- Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women and women who are breastfeeding
- Patients whose clinical status requires that surgery for their HNSCC be performed emergently or in a time course that does not allow scheduling of an 18F-EF5 PET scan preceding surgery and chemoradiation
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 |
|---|---|---|
| fluorine F18 EF5Also: 18F-EF5Given IV | Drug | Arm I |
| immunohistochemistry staining methodAlso: immunohistochemistryCorrelative study | Procedure or surgery | Arm I |
| biopsyAlso: biopsiesCorrelative study | Procedure or surgery | Arm I |
| Positron Emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo scan | Procedure or surgery | Arm I |
Primary outcome
18F-EF5 standardized uptake values (SUV)
Time frame: Study completion
Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.
Tumor to normal tissue (T:N) ratios
Time frame: Study completion
Data on 18F-EF5 signal are collected from multiple sections of the tumor via PET imaging. The outcomes of interest, are 18F-EF5 standardized uptake values (SUV) and/or tumor to normal tissue T:N ratios.
1 secondary outcome
Event-free survival and overall survival
Time frame: 5 years
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 28 Apr 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluorine F18 EF5, immunohistochemistry staining method and biopsy in people with Squamous Cell Carcinoma, run by Abramson Cancer Center at Penn Medicine 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 15 inclusion and 4 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 28 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?
18F-EF5 standardized uptake values (SUV) (time frame: Study completion). 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 28 Apr 2020.