CompletedEarly Phase 1

18F-FLT Positron Emission Tomography and Diffusion-Weighted Magnetic Resonance Imaging in Planning Surgery and Radiation Therapy and Measuring Response in Patients With Newly Diagnosed Ewing Sarcoma

United States1 participantsStarted 2013-03

Plain-language summary

This pilot trial studies fluorine F 18 fluorothymidine (18F-FLT) positron emission tomography and diffusion-weighted magnetic resonance imaging in planing surgery and radiation therapy and measuring response in patients with newly diagnosed Ewing sarcoma. Comparing results of diagnostic procedures done before and after treatment may help doctors predict a patient's response and help plan the best treatment.

Who can participate

Age range

7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histological confirmation of newly diagnosed localized or newly diagnosed with metastatic Ewing sarcoma (ES) or primitive neuroectodermal tumor (PNET) of bone or soft tissue * Planning to receive definitive RT or surgery with or without adjuvant RT * Willing to sign release of information for any follow-up records * Provide informed written consent if \>= 18 years; if \< 18 years, provide informed written assent and parent or legal guardian provide informed written consent * Patients must have measurable disease * Willingness to participate in mandatory imaging studies * Willingness to provide mandatory pathology samples for correlative research Exclusion Criteria: * Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure) * Unable to undergo 18F-FLT PET scan * Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

18F-FLT PET activity

Timeframe: At the time of surgical resection

ADC values from DW-MRI

Timeframe: At the time of surgical resection

18F-FDG PET activity

Timeframe: At the time of surgical resection

MRI contrast enhancement

Timeframe: At the time of surgical resection

Pathologic response

Timeframe: At the time of surgical resection

18F-FLT PET and DW-MRI in predicting local control, event-free survival, and overall survival, measured by therapy-induced changes in the scans

Timeframe: Up to 5 years

Radiotherapy target volume delineation with pre- and post-chemotherapy 18F-FLT PET and DW-MRI

Timeframe: Up to 5 years

Trial details

NCT IDNCT01825902

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01

View on ClinicalTrials.gov More Adult Supratentorial Primitive Neuroectodermal Tumor (PNET) trials

Plain-language summary

Who can participate

Age range

7 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

18F-FLT PET activity

Timeframe: At the time of surgical resection

ADC values from DW-MRI

Timeframe: At the time of surgical resection

18F-FDG PET activity

Timeframe: At the time of surgical resection

MRI contrast enhancement

Timeframe: At the time of surgical resection

Pathologic response

Timeframe: At the time of surgical resection

18F-FLT PET and DW-MRI in predicting local control, event-free survival, and overall survival, measured by therapy-induced changes in the scans

Timeframe: Up to 5 years

Radiotherapy target volume delineation with pre- and post-chemotherapy 18F-FLT PET and DW-MRI

Timeframe: Up to 5 years