Cervical AdenocarcinomaPhase 2NCT00559377
FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
A Phase 2 study testing 18F-fluoromisonidazole, fluorodeoxyglucose F 18 and positron emission tomography in people with Cervical Adenocarcinoma and Cervical Squamous Cell Carcinoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer
- What is being tested?
- 18F-fluoromisonidazole, fluorodeoxyglucose F 18 and positron emission tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to May 2014
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed squamous cell or adenocarcinoma of the uterine cervix
- Clinical stage IB-IVB by FIGO criteria
- Size of the primary tumor ≥ 2 cm as assessed by CT scan
- Measurable disease
- Scheduled to undergo radiotherapy, chemotherapy, or combined multimodality management
- No prior cervical cancer diagnosis
Show all 31Show fewer
- No known brain metastases
- ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%)
- Life expectancy > 12 months
- Not pregnant
- No nursing for 24 hours after fluoromisonidazole F 18 ([^18F] FMISO) PET scanning
- Negative pregnancy test
- Weight ≤ 400 lbs
- Sufficiently healthy to undergo cancer treatment
- Willing to undergo PET scanning with urinary bladder catheterization
- Leukocytes ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin normal
- AST/ALT ≤ 2.5 times normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- No serious medical co-morbidities that would preclude definitive local therapy
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to [^18F] FMISO
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements.
- No prior surgery or radiotherapy for cervical cancer
- Other concurrent investigational agents allowed
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Cervical Cancer
This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will respond to treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- Test the extent to which fluoromisonidazole F 18 ([^18F] FMISO) uptake predicts survival of patients undergoing therapy for newly diagnosed stage IB-IVB cervical cancer.
SECONDARY OBJECTIVES:
- Test [^18F] FMISO tumor uptake as an independent predictor of response to therapy and that it provides additional predictive power over fludeoxyglucose F 18 ([^18F] FDG).
II. Test [^18F] FMISO tumor uptake as a predictor of response in a subgroup of patients receiving radiotherapy.
III. Test the relationship between [^18F] FMISO uptake in the primary tumor and the volume of the primary tumor estimated by CT scan.
IV. Test the reproducibility of [^18F] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol.
- Compare [^18F] FMISO PET or PET/CT scan with [^18F] FDG PET or PET/CT scan to test whether [^18F] FMISO is an independent predictor of treatment outcome.
OUTLINE:
Patients receive fluoromisonidazole F 18 ([^18F] FMISO) IV over 1 minute followed by PET scanning. Patients undergo a second [^18F] FMISO PET scan 4-8 weeks later. Patients who have not had a prior fludeoxyglucose F 18 ([^18F] FDG) PET scan as part of their routine clinical management undergo [^18F] FDG PET scanning at baseline. A subset of 10 patients undergo two [^18F] FMISO PET scans within a 48-hour period to evaluate the variability (test-retest) of this imaging measurement.
Patients response to therapy is followed periodically until time to disease progression or for 2 years.
- Conditions
- Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer
- Being tested
- 18F-fluoromisonidazole, fluorodeoxyglucose F 18, positron emission tomography, tissue oxygen measurement
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-fluoromisonidazoleOther
Also called 18F-FMISO
Undergo ^18F FMISO PET scan
fluorodeoxyglucose F 18Radiation
Also called 18FDG, FDG
Undergo ^18F FDG PET scan
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo ^18F-FMISO and ^18F FDG PET scan
tissue oxygen measurementOther
Undergo ^18 F FMISO PET and ^18F FDG PET
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic FMISO AND FDG PET | Experimental | Patients receive ^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline. Receives: Other: 18F-fluoromisonidazole; Radiation: fluorodeoxyglucose F 18; Procedure: positron emission tomography; Other: tissue oxygen measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.
Measured: For up to 2 years
Disease-free Survival (DFS)
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.
Measured: Up to 2 years
Secondary outcomes (3)
Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor
The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images.
Measured: Up to 2 years
Relationship Between Ki67 and Regional FMISO Uptake in Tumor
The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images.
Measured: Up to 2 years
Response to XRT Using RECIST
Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols
Measured: time to disease progression or 2 years following first FMISO scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2012
- Study completionMay 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 Cervical AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joseph Rajendran, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559377
- Sponsor's protocol ID
- NCI-2009-00257
- Other IDs
- NCI-2009-00257, UW IRB# 6143, 7958, N01CM37008
- Status last verified
- Dec 2016
- First submitted
- 15 Nov 2007
- Last updated
- 30 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Cervical Cancer
- ClinicalTrials.gov ID
- NCT00559377
- Acronym / sponsor ID
- NCI-2009-00257
- Conditions
- Cervical Adenocarcinoma, Cervical Squamous Cell Carcinoma, Stage IB Cervical Cancer, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Posted 26 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will respond to treatment.
Detailed description
PRIMARY OBJECTIVES:
- Test the extent to which fluoromisonidazole F 18 ([^18F] FMISO) uptake predicts survival of patients undergoing therapy for newly diagnosed stage IB-IVB cervical cancer.
SECONDARY OBJECTIVES:
- Test [^18F] FMISO tumor uptake as an independent predictor of response to therapy and that it provides additional predictive power over fludeoxyglucose F 18 ([^18F] FDG).
II. Test [^18F] FMISO tumor uptake as a predictor of response in a subgroup of patients receiving radiotherapy.
III. Test the relationship between [^18F] FMISO uptake in the primary tumor and the volume of the primary tumor estimated by CT scan.
IV. Test the reproducibility of [^18F] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol.
- Compare [^18F] FMISO PET or PET/CT scan with [^18F] FDG PET or PET/CT scan to test whether [^18F] FMISO is an independent predictor of treatment outcome.
OUTLINE:
Patients receive fluoromisonidazole F 18 ([^18F] FMISO) IV over 1 minute followed by PET scanning. Patients undergo a second [^18F] FMISO PET scan 4-8 weeks later. Patients who have not had a prior fludeoxyglucose F 18 ([^18F] FDG) PET scan as part of their routine clinical management undergo [^18F] FDG PET scanning at baseline. A subset of 10 patients undergo two [^18F] FMISO PET scans within a 48-hour period to evaluate the variability (test-retest) of this imaging measurement.
Patients response to therapy is followed periodically until time to disease progression or for 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic FMISO AND FDG PET | Experimental | Other: 18F-fluoromisonidazole, Radiation: fluorodeoxyglucose F 18, Procedure: positron emission tomography, Other: tissue oxygen measurementPatients receive ^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Histologically confirmed squamous cell or adenocarcinoma of the uterine cervix
- Clinical stage IB-IVB by FIGO criteria
- Measurable disease
- Scheduled to undergo radiotherapy, chemotherapy, or combined multimodality management
- No prior cervical cancer diagnosis
Key exclusion criteria (0 listed)
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-fluoromisonidazoleAlso: 18F-FMISOUndergo ^18F FMISO PET scan | Other | Diagnostic FMISO AND FDG PET |
| fluorodeoxyglucose F 18Also: 18FDG, FDGUndergo ^18F FDG PET scan | Radiation | Diagnostic FMISO AND FDG PET |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo ^18F-FMISO and ^18F FDG PET scan | Procedure or surgery | Diagnostic FMISO AND FDG PET |
| tissue oxygen measurementUndergo ^18 F FMISO PET and ^18F FDG PET | Other | Diagnostic FMISO AND FDG PET |
Primary outcome
Overall Survival (OS)
Time frame: For up to 2 years
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables.
Disease-free Survival (DFS)
Time frame: Up to 2 years
Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables.
3 secondary outcomes
Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor
Time frame: Up to 2 years
Relationship Between Ki67 and Regional FMISO Uptake in Tumor
Time frame: Up to 2 years
Response to XRT Using RECIST
Time frame: time to disease progression or 2 years following first FMISO scan
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joseph Rajendran principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-fluoromisonidazole, fluorodeoxyglucose F 18 and positron emission tomography in people with Cervical Adenocarcinoma and Cervical Squamous Cell Carcinoma, run by National Cancer Institute (NCI) 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 31 inclusion and 0 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 30 Dec 2016. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2015). 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?
Overall Survival (OS) (time frame: For up to 2 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 30 Dec 2016.