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Stage II Adult Soft Tissue SarcomaEarly Phase 1NCT03613259

Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue Sarcoma

A Early Phase 1 study testing Fluorothymidine F-18, Laboratory Biomarker Analysis and Positron Emission Tomography in people with Stage II Adult Soft Tissue Sarcoma and Stage IIA Adult Soft Tissue Sarcoma, run by OHSU Knight Cancer Institute.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This pilot early phase I trial studies how well fluorothymidine F-18 positron emission tomography (PET) works in imaging patients with intermediate or high grade soft tissue sarcoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fluorothymidine F-18, Laboratory Biomarker Analysis and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jun 2020to 1 Jun 2022
Phase
Early 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must have histological evidence of an intermediate or high grade soft tissue sarcoma (STS) of any stage
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as >= 1 cm with CT scan or MRI
  • Prior resection is allowed if there is measurable gross disease and the subject plans to have neoadjuvant radiotherapy followed by resection
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 4, Karnofsky performance status >= 40%
  • Creatinine =< 3 x upper limit of normal (ULM)
  • Blood urea nitrogen (BUN) =< 3 x ULN
Show all 14Show fewer
  • Participants should be willing and able to have both PET-CT scans
  • Participants should be eligible for and plan to undergo neoadjuvant radiation therapy and should be seen by a radiation oncologist prior to beginning the study; radiation at an outside facility will be allowed
  • Participants should be eligible for and plan to have resection with a surgeon specializing in STS at Oregon Health and Science University (OHSU) and should be seen by said surgeon prior to beginning the study
  • Participants should have a life expectancy that is greater than the study duration
  • Participants should be willing to use adequate contraception from the time of the first PET-CT scan to 2 months after radiotherapy finishes; should a woman become pregnant while participating in this study, she should inform her treating physician immediately
  • Women with childbearing potential must have a negative pregnancy test before each PET-CT scan
  • Participants should have the ability to understand and the willingness to sign a written informed consent document
  • Participants must sign a study specific consent form prior to registration

Who cannot join

  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded
  • Pregnant women are excluded from this study
  • Breast feeding women are excluded from this study
  • Patients receiving chemotherapy during the course of radiation are excluded
  • Patients whose weights exceed the tolerance of the table are excluded; the weight limit at OHSU is 450 pounds (lbs)

About this study

Official title: A Pilot Study Investigating ¹⁸F-FLT-PET as a Marker of Response to Preoperative Radiotherapy in Soft Tissue Sarcoma

This pilot early phase I trial studies how well fluorothymidine F-18 positron emission tomography (PET) works in imaging patients with intermediate or high grade soft tissue sarcoma. Fluorothymidine F-18 PET may provide useful information about the tumor's response to treatment and may give the doctors early results that would better help to plan the post-surgical therapy.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine fluorothymidine F-18 (¹⁸F-FLT) uptake parameters before and after radiotherapy.

SECONDARY OBJECTIVES:

  1. To correlate ¹⁸F-FLT uptake post-radiotherapy scan with pathologic response. II. To correlate levels the mitotic index in surgical specimens with the ¹⁸F-FLT uptake in post-radiation scans.

III. To correlate ¹⁸F-FLT uptake both pre- and post-radiotherapy with magnetic resonance imaging (MRI) enhancement both within and around the tumor.

TERTIARY OBJECTIVES:

  1. To compare ¹⁸F-FLT uptake and fludeoxyglucose F-18 (FDG) uptake when FDG-PET-computed tomography (CT) is available, pre-radiation, post-radiation, or both.

II. To compare ¹⁸F-FLT uptake in post-radiation scans with local recurrences looking for spatial correlation.

OUTLINE:

Patients receive fluorothymidine F-18 intravenously (IV) over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.

After completion of study, patients are followed up for 2 years.

Being tested
Fluorothymidine F-18, Laboratory Biomarker Analysis, Positron Emission Tomography
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluorothymidine F-18Drug

    Also called ¹⁸F-FLT, 3'-deoxy-3'-(¹⁸F) fluorothymidine, 3'-deoxy-3'-[¹⁸F]fluorothymidine, fluorothymidine F 18

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan

    Undergo fluorothymidine F-18 PET

Study groups in NCT03613259
Study groupRoleWhat they receive
Diagnostic (fluorothymidine F-18 PET)ExperimentalPatients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.
Receives: Drug: Fluorothymidine F-18; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography

What is being measured

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

  1. Change in Fluorothymidine F-18 mean standardized uptake value (SUV) as response to therapy.

    Measured by mean SUV where the response to therapy is Pathological Response Disease change in volume of tumor (in cm3) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) with magnetic resonance imaging (MRI). Mean, median, standard deviation, and range will be reported for continuous variables. Box plot, histogram plot, and density plot may be used to graphically show the distribution of the continuous endpoints.

    Measured: Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

Secondary outcomes (5)

  1. Change in Fluorothymidine F-18 peak SUV as response to therapy

    Measured by peak SUV value where the response to therapy is Pathological Response Disease change in volume of tumor (in cm3) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) with magnetic resonance imaging (MRI). Mean, median, standard deviation, and range will be reported for continuous variables. Box plot, histogram plot, and density plot may be used to graphically show the distribution of the continuous endpoints.

    Measured: Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

  2. Fluorothymidine F-18 mean SUV correlation with pathology mitotic index

    Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans.

    Measured: Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

  3. Fluorothymidine F-18 peak SUV correlation with pathology mitotic index

    Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans.

    Measured: Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

  4. Fluorothymidine F-18 peak SUV correlation with enhancement by MRI

    Measured as Ki-67. Evaluated by the standard of care magnetic resonance imaging. Will assess the size and location of irregularly increased T2-weighted signal intensity. Descriptive statistical analysis will be conducted

    Measured: Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

  5. Volume of T2 enhanced MRI

    Measured in (cm3).

    Measured: Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

Timeline

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

  1. First posted3 Aug 2018
  2. Study start1 Jun 2020 (estimated)
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion1 Jun 2022 (estimated)

Why it stopped: Funding expired

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03613259
Sponsor's protocol ID
STUDY00016373
Other IDs
NCI-2017-00833, SOL-16169-LX, STUDY00016373, P01CA042045, P30CA069533
Status last verified
Jun 2020
First submitted
23 Jan 2018
Last updated
9 Jun 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Fluorothymidine F-18, Laboratory Biomarker Analysis and Positron Emission Tomography in people with Stage II Adult Soft Tissue Sarcoma and Stage IIA Adult Soft Tissue Sarcoma, run by OHSU Knight Cancer Institute.

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 14 inclusion and 5 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: withdrawn, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 withdrawn before enrolling participants, so there are no results.

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 Fluorothymidine F-18 mean standardized uptake value (SUV) as response to therapy. (time frame: Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography). 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 NCT03613259.

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 9 Jun 2020.

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