Uterine Cervical NeoplasmsPhase 2NCT01075412

FLT PET Imaging for Cervical Cancer

A Phase 2 study testing [F18]Fluorothymidine in people with Uterine Cervical Neoplasms, run by University of Iowa at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to metabolically active tumor. This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Uterine Cervical Neoplasms
What is being tested?: [F18]Fluorothymidine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Sep 2009to 11 Apr 2016
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

Ability to understand and willingness to sign a written informed consent document.
Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
Scheduled to receive chemo-radiation for oncologic treatment.
Karnofsky of at least 60 at time of screening
Life expectancy of at least 6 months.
Leukocytes at least 3,000/microL

Show all 12Show fewer

absolute neutrophil count at least 1,500/microL
platelets at least 100,000/microL
total bilirubin at maximum 1.0 mg/dL (UIHC limit of normal)
either ALT or AST less than 2.5 times the upper limit of normal
creatinine less than 1.5 times the upper limit of normal
non-pregnant, non-nursing, willing to use contraception

Who cannot join

oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
subjects taking nucleoside analog medications such as those used as antiretroviral agents.
patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: 'F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer

Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to metabolically active tumor.

This trial will use FLT-PET imaging to define areas of active bone marrow in the pelvis. The radiation plan is then designed to spare that area, in hopes of keeping the bone marrow active during therapy. Bone marrow and tumor activity will be monitored using a sequence of FLT PET scans during the course of chemotherapy and radiation therapy.

Read the detailed description

Subjects will undergo a total of up to 5 FLT PET scans.

Subjects are randomized between two groups to reduce radiation exposure from the FLT PET scans. If bone marrow activity is not identified in one scan, further scans are cancelled until the 1-month follow up scan. This is not a randomization to compare therapeutic efficacy between two study arms. Data will be pooled for analysis as pre-specified in the study's statistical plan.

Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy.

Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.

Conditions: Uterine Cervical Neoplasms
Being tested: [F18]Fluorothymidine
Keywords: Positron-Emission Tomography, Radiotherapy, Intensity-Modulated
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.

[F18]FluorothymidineDrug
Also called FLT
FLT PET scan 5 mCi (+/- 10%)

Study groups in NCT01075412
Study group	Role	What they receive
Group 2	Experimental	Receives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy. Receives: Drug: [F18]Fluorothymidine
Group 1	Experimental	Receives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy. Receives: Drug: [F18]Fluorothymidine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Difference From Baseline IMRT Plan (%)
The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation dose bins evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.
Measured: Baseline (pre-treatment)

Secondary outcomes (5)

Chemotherapy Compliance
The number of participants who missed at least one prescribed chemotherapy administration due to low blood counts.
Measured: post-treatment
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
White blood cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured weekly during combined chemotherapy and radiation therapy treatment and then once at 30 day follow-up and at 1 year follow-up
Measured: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Platelet cell counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Measured: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Absolute neutrophil counts (ANCs) measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up.
Measured: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Lymphocyte counts measurements expressed in standardized toxicity severity grades (Common Terminology Criteria for Adverse Events, v4.03) measured once weekly during combined chemotherapy and radiation therapy, then once at 30 day follow-up, and once at 1 year follow-up
Measured: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 200911 Apr 2016

First posted25 Feb 2010 (estimated)
Study startSep 2009
Primary completion3 Mar 2016
Study completion11 Apr 2016

Why it stopped: Study was closed and reopened as NCT01717391

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.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Uterine Cervical NeoplasmsStudies 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01075412
Sponsor's protocol ID: 200906786
Status last verified: Oct 2017
First submitted: 23 Feb 2010
Last updated: 2 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Yes, data will be shared utilizing clinicaltrials.gov results

Publications

McGuire SM, Menda Y, Ponto LL, Gross B, Juweid M, Bayouth JE. A methodology for incorporating functional bone marrow sparing in IMRT planning for pelvic radiation therapy. Radiother Oncol. 2011 Apr;99(1):49-54. doi: 10.1016/j.radonc.2011.01.025. Epub 2011 Mar 22.
PubMed 21397965
McGuire SM, Menda Y, Boles Ponto LL, Gross B, Buatti J, Bayouth JE. 3'-deoxy-3'-[(1)(8)F]fluorothymidine PET quantification of bone marrow response to radiation dose. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):888-93. doi: 10.1016/j.ijrobp.2010.12.009. Epub 2011 Feb 6.
PubMed 21300484
Menda Y, Ponto LL, Dornfeld KJ, Tewson TJ, Watkins GL, Gupta AK, Anderson C, McGuire S, Schultz MK, Sunderland JJ, Graham MM, Buatti JM. Investigation of the pharmacokinetics of 3'-deoxy-3'-[18F]fluorothymidine uptake in the bone marrow before and early after initiation of chemoradiation therapy in head and neck cancer. Nucl Med Biol. 2010 May;37(4):433-8. doi: 10.1016/j.nucmedbio.2010.02.005.
PubMed 20447554
McGuire SM, Bhatia SK, Sun W, Jacobson GM, Menda Y, Ponto LL, Smith BJ, Gross BA, Bayouth JE, Sunderland JJ, Graham MM, Buatti JM. Using [(18)F]Fluorothymidine Imaged With Positron Emission Tomography to Quantify and Reduce Hematologic Toxicity Due to Chemoradiation Therapy for Pelvic Cancer Patients. Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):228-39. doi: 10.1016/j.ijrobp.2016.04.009. Epub 2016 Apr 19.
PubMed 27319286
McGuire SM, Menda Y, Ponto LLB, Gross B, TenNapel M, Smith BJ, Bayouth JE. Spatial mapping of functional pelvic bone marrow using FLT PET. J Appl Clin Med Phys. 2014 Jul 8;15(4):129-136. doi: 10.1120/jacmp.v15i4.4780.
PubMed 25207403

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Uterine Cervical Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 'F-18 Fluorothymidine ([18F]FLT) PET Imaging for Early Evaluation of Response to Chemoradiation Therapy in Patients With Cervical Cancer
ClinicalTrials.gov ID: NCT01075412
Acronym / sponsor ID: 200906786
Conditions: Uterine Cervical Neoplasms
Keywords: Positron-Emission Tomography, Radiotherapy, Intensity-Modulated
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was closed and reopened as NCT01717391
Enrolment: 6 participants (actual)
Lead sponsor: University of IowaUniversity, hospital or other
Collaborators: Holden Comprehensive Cancer Center
Study start: Sep 2009 (actual)
Primary completion: 3 Mar 2016 (actual)
Study completion: 11 Apr 2016 (actual)
First posted: 25 Feb 2010 (estimated)
Results: Posted 2 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Our primary hypothesis is that [18F]FLT PET can identify active bone marrow in addition to metabolically active tumor.

Detailed description

Subjects will undergo a total of up to 5 FLT PET scans.

Group 1 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 15 radiation treatments, and then 1 month after completing radiation therapy.

Group 2 has FLT PET scans pretreatment, after 5 radiation treatments, after 10 radiation treatments, after 20 radiation treatments, and then 1 month after completing radiation therapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 2	Experimental	Drug: [F18]FluorothymidineReceives fourth [F18]Fluorothymidine (FLT) PET scan after 20 fractions of radiation therapy.
Group 1	Experimental	Drug: [F18]FluorothymidineReceives fourth [F18]Fluorothymidine (FLT) PET scan after 15 fractions of radiation therapy.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Ability to understand and willingness to sign a written informed consent document.
Histologically confirmed stage IB2, IIA, IIB, IIIB, and IVA squamous cell carcinoma of the cervix.
Scheduled to receive chemo-radiation for oncologic treatment.
Karnofsky of at least 60 at time of screening
Life expectancy of at least 6 months.

Key exclusion criteria (4 listed)

oncology research protocol requiring full pelvic radiation (i.e., 4-field box technique) or experimental chemotherapy
uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
subjects taking nucleoside analog medications such as those used as antiretroviral agents.
patients who have undergone hysterectomy or will have a hysterectomy as part of their cancer therapy.

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
[F18]FluorothymidineAlso: FLTFLT PET scan 5 mCi (+/- 10%)	Drug	Group 1, Group 2

Primary outcome

Percent Difference From Baseline IMRT Plan (%)
Time frame: Baseline (pre-treatment)
The difference in volume of bone marrow receiving radiation using a bone-marrow-sparing radiation plan compared to a standard radiation plan (IMRT), expressed as a percentage. Both plans are patient-specific. Bone-marrow is identified using the baseline FLT PET/CT obtained pre-imaging. Active bone marrow is considered to have an uptake value (SUV) of 2, 3, or 4. The standard IMRT plan was created using the criteria of the National Cancer Institute's Radiation Therapy Oncology Group study RTOG-0418. Radiation dose bins evaluated are 5 Gray, 10 Gray, 20 Gray, and 30 Gray. The change in dose to tumor is also provided. A negative value indicates that more bone marrow or tissue was spared using the bone-marrow sparing plan.

5 secondary outcomes

Chemotherapy Compliance
Time frame: post-treatment
Number of Participants With Standardized Toxicity Severity Grades for White Blood Cell Counts
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Platelet Counts.
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Absolute Neutrophil Counts (ANCs)
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment
Number of Participants With Standardized Toxicity Severity Grades for Decreased Lymphocyte Counts.
Time frame: baseline, weekly during radiation treatment for up to 5 weeks, and 30 days post treatment

Results and safety

Results posted to the registry on 2 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	4	4
Group 2	2	1

Primary outcome: Percent Difference From Baseline IMRT Plan (%)

Time frame: Baseline (pre-treatment). Mean (Standard Deviation). Unit: Percent difference (%)

Measure	All Participants n = 5
% difference, volume receiving 5 Gray	-8.5 (6.0)
% difference, volume receiving 10 Gray	-11.7 (7.3)
% difference, volume receiving 20 Gray	-15.8 (3.8)
% difference, volume receiving 30 Gray	-16.5 (12.6)
% difference, dose to target (tumor) volume	-0.2 (0.1)

Population analysed: Participants who received an FLT PET/CT during radiation simulation and did not withdraw from study participation. Groups 1 and 2 were combined as pre-specified in the study protocol, as the groups were separated only to reduce radiation risk from FLT PET imaging (and not for therapeutic comparison).

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the time of FLT injection through 24 hours post-injection.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Group 2	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): The results of this pilot study were merged with NCT01717391 for analysis and resultant publication.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21397965McGuire SM, Menda Y, Ponto LL, Gross B, Juweid M, Bayouth JE. A methodology for incorporating functional bone marrow sparing in IMRT planning for pelvic radiation therapy. Radiother Oncol. 2011 Apr;99(1):49-54. doi: 10.1016/j.radonc.2011.01.025. Epub 2011 Mar 22.
Background: PubMed 21300484McGuire SM, Menda Y, Boles Ponto LL, Gross B, Buatti J, Bayouth JE. 3'-deoxy-3'-[(1)(8)F]fluorothymidine PET quantification of bone marrow response to radiation dose. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):888-93. doi: 10.1016/j.ijrobp.2010.12.009. Epub 2011 Feb 6.
Background: PubMed 20447554Menda Y, Ponto LL, Dornfeld KJ, Tewson TJ, Watkins GL, Gupta AK, Anderson C, McGuire S, Schultz MK, Sunderland JJ, Graham MM, Buatti JM. Investigation of the pharmacokinetics of 3'-deoxy-3'-[18F]fluorothymidine uptake in the bone marrow before and early after initiation of chemoradiation therapy in head and neck cancer. Nucl Med Biol. 2010 May;37(4):433-8. doi: 10.1016/j.nucmedbio.2010.02.005.
Results publication: PubMed 27319286McGuire SM, Bhatia SK, Sun W, Jacobson GM, Menda Y, Ponto LL, Smith BJ, Gross BA, Bayouth JE, Sunderland JJ, Graham MM, Buatti JM. Using [(18)F]Fluorothymidine Imaged With Positron Emission Tomography to Quantify and Reduce Hematologic Toxicity Due to Chemoradiation Therapy for Pelvic Cancer Patients. Int J Radiat Oncol Biol Phys. 2016 Sep 1;96(1):228-39. doi: 10.1016/j.ijrobp.2016.04.009. Epub 2016 Apr 19.
Results publication: PubMed 25207403McGuire SM, Menda Y, Ponto LLB, Gross B, TenNapel M, Smith BJ, Bayouth JE. Spatial mapping of functional pelvic bone marrow using FLT PET. J Appl Clin Med Phys. 2014 Jul 8;15(4):129-136. doi: 10.1120/jacmp.v15i4.4780.
Individual participant dataSharing planned: Yes. Yes, data will be shared utilizing clinicaltrials.gov results

Related trials for Uterine Cervical Neoplasms

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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.

Michael M Graham, Ph.D., M.D. study director

University of Iowa

Sarah McGuire, Ph.D. principal investigator

University of Iowa

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 [F18]Fluorothymidine in people with Uterine Cervical Neoplasms, 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 12 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: stopped early, as of the sponsor's last update on 2 Dec 2017. 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 2 Dec 2017). 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?

Percent Difference From Baseline IMRT Plan (%) (time frame: Baseline (pre-treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01075412, which also lists 5 linked publications.

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 2 Dec 2017.