Cervical CancerPhase 1NCT02317302
FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer
A Phase 1 study testing FDG-PET/MR and FDG-PET/CT in people with Cervical Cancer and Uterine Cervical Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Uterine Cervical Cancer, Uterine Cervical Neoplasms
- What is being tested?
- FDG-PET/MR and FDG-PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2011to 2 Jun 2020
- Phase
- Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have biopsy-proven cervical cancer (FIGO stage-Ib2-IVb).
- Patient must be at least18 years of age.
- Patient must be planning to receive chemoradiation therapy with cisplatin.
- Patient must have non-pregnant status if a female of childbearing potential. Women who have had a tubal ligation at least 12 months prior to study entry or a hysterectomy will be considered NOT of childbearing potential. Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered NOT of childbearing potential.
- Patient may have distant metastatic disease provided the estimated survival is at least 1 year.
- Patient's tumor(s) must be FDG avid on baseline standard of care FDG-PET/CT or PET/MR imaging that was performed at Barnes-Jewish Hospital Clinical PET Facility.
- Patient must be able and willing to give informed consent.
- If the patient will be scanned on the PET/MR for the mid-treatment scan, they must be determined to be safe for exposure to the magnetic field. This will be determined the day of imaging by the technologist with the use of a screening form. If a patient is not safe for the PET/MR scanner, their mid-treatment images will occur on the PET/CT scanner in the Center for Clinical Imaging Research.
Who cannot join
- Patient must have no other active cancer at the time of diagnosis of cervical cancer.
- Patient cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
- Patient must not be an uncontrolled diabetic with a glucose of ≥ 200mg/dl at the time of PET imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response to Concurrent Radiation Therapy and Chemotherapy in Patients With Cervical Cancer
In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging, have evaluated changes in the cervical tumor volume during treatment. The investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.
- Being tested
- FDG-PET/MR, FDG-PET/CT
- 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.
FDG-PET/MRDevice
Also called PET/MR
FDG-PET/CTDevice
Also called PET/CT
| Study group | Role | What they receive |
|---|---|---|
| FDG-PET/CT or FDG-PET/MR | Experimental | * Standard of care FDG-PET/CT or FDG-PET/MR at baseline
* FDG-PET/CT or FDG-PET/MR after the 2nd but before the 3rd brachytherapy treatment
* Standard of care 3 month post treatment FDG-PET/CT or FDG-PET/MR
* We will perform the research-related FDG-PET on the PET/MR rather than the PET/CT if the patient is safe to undergo MR and agrees to undergo MR.
* The standard of care imaging may be performed on the PET/CT scanner or the PET/MR scanner. Receives: Device: FDG-PET/MR; Device: FDG-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FDG heterogeneity (Using texture analysis)
Using texture analysis
Measured: Up to 5 years
Change in SUVmax (SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness)
SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness.
Measured: Up to 5 years
Secondary outcomes (2)
Response to therapy based on FDG heterogeneity
Measured: Up to 5 years
Response to therapy based on SUVmax
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study start28 Jun 2011
- Primary completion2 Jun 2020
- Study completion2 Jun 2020
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perry Grigsby, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317302
- Sponsor's protocol ID
- 201104322
- Status last verified
- Jun 2020
- First submitted
- 10 Dec 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response to Concurrent Radiation Therapy and Chemotherapy in Patients With Cervical Cancer
- ClinicalTrials.gov ID
- NCT02317302
- Acronym / sponsor ID
- 201104322
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 28 Jun 2011 (actual)
- Primary completion
- 2 Jun 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 16 Dec 2014 (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.
In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging, have evaluated changes in the cervical tumor volume during treatment. The investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDG-PET/CT or FDG-PET/MR | Experimental | Device: FDG-PET/MR, Device: FDG-PET/CT* Standard of care FDG-PET/CT or FDG-PET/MR at baseline * FDG-PET/CT or FDG-PET/MR after the 2nd but before the 3rd brachytherapy treatment * Standard of care 3 month post treatment FDG-PET/CT or FDG-PET/MR * We will perform the research-related FDG-PET on the PET/MR rather than the PET/CT if the patient is safe to undergo MR and agrees to undergo MR. * The standard of care imaging may be performed on the PET/CT scanner or the PET/MR scanner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient must have biopsy-proven cervical cancer (FIGO stage-Ib2-IVb).
- Patient must be at least18 years of age.
- Patient must be planning to receive chemoradiation therapy with cisplatin.
- Patient must have non-pregnant status if a female of childbearing potential. Women who have had a tubal ligation at least 12 months prior to study entry or a hysterectomy will be considered NOT of childbearing potential. Postmenopausal women must have been amenorrheic for at least 12 consecutive months to be considered NOT of childbearing potential.
- Patient may have distant metastatic disease provided the estimated survival is at least 1 year.
Key exclusion criteria (3 listed)
- Patient must have no other active cancer at the time of diagnosis of cervical cancer.
- Patient cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years.
- Patient must not be an uncontrolled diabetic with a glucose of ≥ 200mg/dl at the time of PET imaging.
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 |
|---|---|---|
| FDG-PET/MRAlso: PET/MR | Device | FDG-PET/CT or FDG-PET/MR |
| FDG-PET/CTAlso: PET/CT | Device | FDG-PET/CT or FDG-PET/MR |
Primary outcome
Change in FDG heterogeneity (Using texture analysis)
Time frame: Up to 5 years
Using texture analysis
Change in SUVmax (SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness)
Time frame: Up to 5 years
SUVmax - maximum standardized uptake value = is a marker of tumor glucose metabolism and reflects tumor aggressiveness.
2 secondary outcomes
Response to therapy based on FDG heterogeneity
Time frame: Up to 5 years
Response to therapy based on SUVmax
Time frame: Up to 5 years
Results and safety
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Perry Grigsby, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FDG-PET/MR and FDG-PET/CT in people with Cervical Cancer and Uterine Cervical Cancer, run by Washington University School of 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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 11 Jun 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
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?
Change in FDG heterogeneity (Using texture analysis) (time frame: Up to 5 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 11 Jun 2020.