SarcomaNCT00335751
PET Scan Combined With CT Scan in Evaluating Treatment Response in Patients Undergoing Treatment for Bone Cancer or Soft Tissue Sarcoma
A study testing positron emission tomography computed tomography (PET/CT) in people with Sarcoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- positron emission tomography computed tomography (PET/CT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Oct 2011
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed bone or soft tissue sarcoma
- Scheduled to undergo treatment (i.e., chemotherapy and/or radiotherapy) for sarcoma
- Negative pregnancy test
- Fertile patients must use effective contraception
- Not claustrophobic
- Able to lie supine for 1 hour
- Patients with diabetes mellitus allowed provided serum glucose levels ≤ 200 mg/dL
Who cannot join
- pregnant
- other malignancies within the past 5 years (except completely resected cervical or nonmelanoma skin cancer) unless the malignancy was curatively treated and is at low risk for recurrence
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Glucose Metabolic Response by PET/CT to Sarcoma Treatments
RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.
Read the detailed description
OBJECTIVES:
- Determine whether an FDA-approved device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
- Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
- Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
- Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
- Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.
OUTLINE: This is a prospective, pilot study. Patients are stratified according to disease (high-grade soft tissue sarcoma vs low-grade soft tissue sarcoma vs osteosarcoma).
Patients undergo fludeoxyglucose ^18F positron-emission tomography (FDG-PET)/CT scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans).
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
- Conditions
- Sarcoma
- Being tested
- positron emission tomography computed tomography (PET/CT)
- Keywords
- recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, localized osteosarcoma, metastatic osteosarcoma, recurrent osteosarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
- Medical subject headings
- Sarcoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
positron emission tomography computed tomography (PET/CT)Procedure or surgery
The first PET/CT scan will be performed as part of clinical evaluation of sarcoma; The second PET/CT scan will be performed 6 weeks after the start of chemotherapy treatment OR 6 weeks after the end of radiation therapy, to monitor response of sarcoma to treatment.
| Study group | Role | What they receive |
|---|---|---|
| positron emission tomography computed tomography (PET/CT) | Experimental | The first PET/CT scan will be performed as part of clinical evaluation of sarcoma; The second PET/CT scan will be performed 6 weeks after the start of chemotherapy treatment OR 6 weeks after the end of radiation therapy, to monitor response of sarcoma to treatment. Receives: Procedure: positron emission tomography computed tomography (PET/CT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
Measured: 6 months
Secondary outcomes (4)
•Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
Measured: 6 months
•Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
Measured: 6 months
•Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
Measured: 6 months
•Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2006 (estimated)
- Study startJan 2006
- Primary completionJul 2008
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johannes Czernin, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335751
- Sponsor's protocol ID
- CDR0000480348
- Other IDs
- UCLA-0508095-01
- Status last verified
- Jan 2016
- First submitted
- 8 Jun 2006
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Metabolic Response by PET/CT to Sarcoma Treatments
- ClinicalTrials.gov ID
- NCT00335751
- Acronym / sponsor ID
- CDR0000480348
- Conditions
- Sarcoma
- Keywords
- recurrent adult soft tissue sarcoma, stage I adult soft tissue sarcoma, localized osteosarcoma, metastatic osteosarcoma, recurrent osteosarcoma, stage II adult soft tissue sarcoma, stage III adult soft tissue sarcoma, stage IV adult soft tissue sarcoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Jun 2006 (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.
RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment.
PURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.
Detailed description
OBJECTIVES:
- Determine whether an FDA-approved device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
- Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
- Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
- Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
- Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.
OUTLINE: This is a prospective, pilot study. Patients are stratified according to disease (high-grade soft tissue sarcoma vs low-grade soft tissue sarcoma vs osteosarcoma).
Patients undergo fludeoxyglucose ^18F positron-emission tomography (FDG-PET)/CT scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans).
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| positron emission tomography computed tomography (PET/CT) | Experimental | Procedure: positron emission tomography computed tomography (PET/CT)The first PET/CT scan will be performed as part of clinical evaluation of sarcoma; The second PET/CT scan will be performed 6 weeks after the start of chemotherapy treatment OR 6 weeks after the end of radiation therapy, to monitor response of sarcoma to treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed bone or soft tissue sarcoma
- Scheduled to undergo treatment (i.e., chemotherapy and/or radiotherapy) for sarcoma
- Negative pregnancy test
- Fertile patients must use effective contraception
- Not claustrophobic
Key exclusion criteria (2 listed)
- pregnant
- other malignancies within the past 5 years (except completely resected cervical or nonmelanoma skin cancer) unless the malignancy was curatively treated and is at low risk for recurrence
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 |
|---|---|---|
| positron emission tomography computed tomography (PET/CT)The first PET/CT scan will be performed as part of clinical evaluation of sarcoma; The second PET/CT scan will be performed 6 weeks after the start of chemotherapy treatment OR 6 weeks after the end of radiation therapy, to monitor response of sarcoma to treatment. | Procedure or surgery | positron emission tomography computed tomography (PET/CT) |
Primary outcome
Determine whether device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
Time frame: 6 months
4 secondary outcomes
•Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
Time frame: 6 months
•Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
Time frame: 6 months
•Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
Time frame: 6 months
•Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.
Time frame: 6 months
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 31 Jul 2020.
- 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.
Johannes Czernin, MD study chair
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing positron emission tomography computed tomography (PET/CT) in people with Sarcoma, run by Jonsson Comprehensive Cancer Center 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 7 inclusion and 2 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 31 Jul 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.
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.
What does the primary outcome measure?
Determine whether device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine disease in patients who are undergoing treatment for bone or soft tissue sarcoma. (time frame: 6 months). 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 31 Jul 2020.