Head and Neck CancerNCT00245349
Study to Calculate the Radiation Dosimetry in Subjects With Head and Neck Cancer
An observational study of Head and Neck Cancer, run by University of Iowa at 1 site in United States.
Trial summary
Preliminary observations suggest positron emission tomography (PET) imaging with an F-18 labeled thymidine analog (FLT) can selectively identify proliferating and non-proliferating tissues, including tumors. FLT uptake in the tumor appears to reflect the level of cells undergoing DNA synthesis. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- F-18 Fluorothymidine
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Apr 2008
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Head \& Neck Cancer
Who may be able to join
- Ability to understand and willingness to sign a written informed consent document.
- Subject must have histologically confirmed stage III, or IV squamous cell carcinoma of the head and neck whose primary origin was from the oral cavity, oropharynx, hypopharynx, or larynx. Carcinoma must be staged using the American Joint Committee on Cancer (AJCC) staging criteria version 6. Adequate tumor must be amenable to biopsy via outpatient methods, therefore the majority of subjects will be those with oropharyngeal lesions.
- Subjects must be scheduled to receive combined chemo-radiotherapy treatment for their standard cancer care. Treatment decisions will be made by the treating otolaryngologist, radiation, and medical oncologists.
- Males or females greater than or equal to 21 years of age. Squamous cell cancer of the head and neck is exceedingly rare in children and not generally applicable to the pediatric population.
- Karnofsky score greater than or equal to 60% at time of screening.
- Life expectancy of greater than 6 months.
Show all 16Show fewer
- Subject must have normal organ and marrow function as defined below:
- leukocytes greater than or equal to 3,000/microL
- absolute neutrophil count greater than or equal to 1,500/microL
- platelets greater than or equal to 100,000/microL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal
- creatinine within normal institutional limits
- BUN within normal institutional limits
- PT and PTT < 2.0 X upper normal limits
- The effects of FLT on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A screening urine hCG will be administered to women of childbearing potential before each FLT scan.
Who cannot join
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Subject may not be receiving any other investigational agents.
- Subject with a Karnofsky score below 60.
- Pregnant women are excluded from this study. FLT PET has the potential for teratogenic effects. Because there are potentially unknown risks for adverse events in nursing infants secondary to treatment of the mother with FLT, breastfeeding should be discontinued if the mother is imaged with FLT and may not resume for 48 hours after the FLT imaging.
- Subject with an inadequate marrow reserve as determined by history and/or the above tests.
- Subject with a bleeding or clotting dysfunction as determined by medical history and above tests.
- Subjects taking nucleoside analog medications such as those used as antiretroviral agents.
- Inadequate tumor volume to allow for 2 biopsies.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Biodistribution and Radiation Dosimetry of F-18 Fluorothymidine (FLT) Imaged With Positron Emission Tomography (PET) in Patients With Head and Neck Cancer: A Radioactive Drug Research Committee (RDRC) Study
Preliminary observations suggest positron emission tomography (PET) imaging with an F-18 labeled thymidine analog (FLT) can selectively identify proliferating and non-proliferating tissues, including tumors. FLT uptake in the tumor appears to reflect the level of cells undergoing DNA synthesis. This is clinically important because cell proliferation markers have significant prognostic value, both prior to initiating radiotherapy and as they change during the course of therapy. In the proposed study, the researchers assess the biodistribution and radiation dosimetry of FLT to obtain the necessary data to file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). The information collected under Radioactive Drug Research Committee (RDRC) approval will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.
Read the detailed description
There are approximately 40,000 new cases of head and neck cancer each year in the United States. Worldwide more than 500,000 individuals will develop head and neck cancer each year, ranking as the sixth most common cancer. These cancers are predominately squamous cell cancers. Approximately two thirds of subjects will present with locally advanced disease with either large disease at the primary site and/or spread to regional lymph node levels.
Despite aggressive treatment, 5-year survival remains poor (overall, approximately 50%). The major site of treatment failure is within the head and neck region, with distant metastases occurring in approximately 25% of subjects and usually after local and/or regional (nodal) failure.
Current treatment options for locally advanced head and neck cancer include combinations of surgery, radiation therapy, and chemotherapy. It is currently difficult to predict which combination will be best suited for any particular individual. Rapid methods of assessing the response of subjects to chemo-radiotherapy would be a useful tool, as it would permit the oncologist to change therapies, either in type or degree, in cases when the subject does not respond to the initial therapy regimen. Current best methods of evaluating tumor response are either serial CT examinations, so that changes in tumor size can be estimated or a fluorodeoxyglucose (FDG) positron emission tomography (PET) study in which changes in the metabolic status of the tumor are evaluated. Unfortunately, the anatomic information afforded by CT examinations often require months after treatment to allow the full effects of therapy to take place. Even after this time, the metabolic activity of any remaining tissue is nearly impossible to assess by CT scan, making it difficult to distinguish between fibrosis and viable tissue. Generally the FDG studies require 3-4 weeks after the end of the therapeutic regime before the relevant information is available, with more reliable information obtained at 3-4 months after treatment.
It is predictable that the most immediate signal of an anti-tumor therapeutic regime that has been successful is that the tumor cells will stop dividing (proliferating) after the therapy is initiated. Therefore, a tracer which is taken up into and retained in cells as a function of their proliferative activity should provide rapid information as to the effectiveness of the treatment. It is the objective of this study to determine the biodistribution and radiation dosimetry of tracer F-18 3'-deoxy-3'-fluorothymidine. This distribution data is essential before an Investigational New Drug (IND) application can be filed with the FDA that would allow the use of this tracer in clinical trials.
- Conditions
- Head and Neck Cancer
- Being tested
- F-18 Fluorothymidine
- Keywords
- Head and Neck cancer, Squamous cell carcinoma, FLT, Fluorothymidine, F-18
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 FluorothymidineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| FLT | Study group receiving FLT for imaging Receives: Procedure: F-18 Fluorothymidine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startOct 2005
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Investigators
- Yusuf Menda, MD, Principal investigator, University of Iowa, Department of Radiology-Nuclear MedicineKenneth J Dornfeld, MD, PhD, Principal investigator, University of IowaTimothy Tewson, PhD, Principal investigator, University of Iowa, Department of Radiology-Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245349
- Sponsor's protocol ID
- 200502799
- Status last verified
- Jun 2008
- First submitted
- 25 Oct 2005
- Last updated
- 10 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biodistribution and Radiation Dosimetry of F-18 Fluorothymidine (FLT) Imaged With Positron Emission Tomography (PET) in Patients With Head and Neck Cancer: A Radioactive Drug Research Committee (RDRC) Study
- ClinicalTrials.gov ID
- NCT00245349
- Acronym / sponsor ID
- 200502799
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck cancer, Squamous cell carcinoma, FLT, Fluorothymidine, F-18
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Apr 2008 (actual)
- First posted
- 27 Oct 2005 (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.
Preliminary observations suggest positron emission tomography (PET) imaging with an F-18 labeled thymidine analog (FLT) can selectively identify proliferating and non-proliferating tissues, including tumors. FLT uptake in the tumor appears to reflect the level of cells undergoing DNA synthesis. This is clinically important because cell proliferation markers have significant prognostic value, both prior to initiating radiotherapy and as they change during the course of therapy. In the proposed study, the researchers assess the biodistribution and radiation dosimetry of FLT to obtain the necessary data to file an Investigational New Drug (IND) application with the Food and Drug Administration (FDA). The information collected under Radioactive Drug Research Committee (RDRC) approval will not be used for diagnostic purposes, to assess the subject's response to therapy, or for clinical management of the subject.
Detailed description
There are approximately 40,000 new cases of head and neck cancer each year in the United States. Worldwide more than 500,000 individuals will develop head and neck cancer each year, ranking as the sixth most common cancer. These cancers are predominately squamous cell cancers. Approximately two thirds of subjects will present with locally advanced disease with either large disease at the primary site and/or spread to regional lymph node levels.
Despite aggressive treatment, 5-year survival remains poor (overall, approximately 50%). The major site of treatment failure is within the head and neck region, with distant metastases occurring in approximately 25% of subjects and usually after local and/or regional (nodal) failure.
Current treatment options for locally advanced head and neck cancer include combinations of surgery, radiation therapy, and chemotherapy. It is currently difficult to predict which combination will be best suited for any particular individual. Rapid methods of assessing the response of subjects to chemo-radiotherapy would be a useful tool, as it would permit the oncologist to change therapies, either in type or degree, in cases when the subject does not respond to the initial therapy regimen. Current best methods of evaluating tumor response are either serial CT examinations, so that changes in tumor size can be estimated or a fluorodeoxyglucose (FDG) positron emission tomography (PET) study in which changes in the metabolic status of the tumor are evaluated. Unfortunately, the anatomic information afforded by CT examinations often require months after treatment to allow the full effects of therapy to take place. Even after this time, the metabolic activity of any remaining tissue is nearly impossible to assess by CT scan, making it difficult to distinguish between fibrosis and viable tissue. Generally the FDG studies require 3-4 weeks after the end of the therapeutic regime before the relevant information is available, with more reliable information obtained at 3-4 months after treatment.
It is predictable that the most immediate signal of an anti-tumor therapeutic regime that has been successful is that the tumor cells will stop dividing (proliferating) after the therapy is initiated. Therefore, a tracer which is taken up into and retained in cells as a function of their proliferative activity should provide rapid information as to the effectiveness of the treatment. It is the objective of this study to determine the biodistribution and radiation dosimetry of tracer F-18 3'-deoxy-3'-fluorothymidine. This distribution data is essential before an Investigational New Drug (IND) application can be filed with the FDA that would allow the use of this tracer in clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLT | – | Procedure: F-18 FluorothymidineStudy group receiving FLT for imaging |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Head \& Neck Cancer
Key inclusion criteria (16 listed)
- Ability to understand and willingness to sign a written informed consent document.
- Subject must have histologically confirmed stage III, or IV squamous cell carcinoma of the head and neck whose primary origin was from the oral cavity, oropharynx, hypopharynx, or larynx. Carcinoma must be staged using the American Joint Committee on Cancer (AJCC) staging criteria version 6. Adequate tumor must be amenable to biopsy via outpatient methods, therefore the majority of subjects will be those with oropharyngeal lesions.
- Subjects must be scheduled to receive combined chemo-radiotherapy treatment for their standard cancer care. Treatment decisions will be made by the treating otolaryngologist, radiation, and medical oncologists.
- Males or females greater than or equal to 21 years of age. Squamous cell cancer of the head and neck is exceedingly rare in children and not generally applicable to the pediatric population.
- Karnofsky score greater than or equal to 60% at time of screening.
Key exclusion criteria (8 listed)
- Subjects who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Subject may not be receiving any other investigational agents.
- Subject with a Karnofsky score below 60.
- Pregnant women are excluded from this study. FLT PET has the potential for teratogenic effects. Because there are potentially unknown risks for adverse events in nursing infants secondary to treatment of the mother with FLT, breastfeeding should be discontinued if the mother is imaged with FLT and may not resume for 48 hours after the FLT imaging.
- Subject with an inadequate marrow reserve as determined by history and/or the above tests.
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 |
|---|---|---|
| F-18 Fluorothymidine | Procedure or surgery | FLT |
Primary outcome
Not reported in the source record.
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 10 Jun 2008.
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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.
Yusuf Menda, MD principal investigator
University of Iowa, Department of Radiology-Nuclear Medicine
Kenneth J Dornfeld, MD, PhD principal investigator
University of Iowa
Timothy Tewson, PhD principal investigator
University of Iowa, Department of Radiology-Nuclear Medicine
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 Head and Neck Cancer, run by University of Iowa 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 16 inclusion and 8 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 10 Jun 2008. 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.
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 10 Jun 2008.