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18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma

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ClinicalTrials.gov Identifier: NCT04365660
Recruitment Status : Terminated (lack of accrual with no intent of continuing)
First Posted : April 28, 2020
Results First Posted : November 14, 2023
Last Update Posted : November 14, 2023
Sponsor:
Information provided by (Responsible Party):
Kristen Ganjoo, Stanford University

Tracking Information
First Submitted Date  ICMJE April 24, 2020
First Posted Date  ICMJE April 28, 2020
Results First Submitted Date  ICMJE September 28, 2023
Results First Posted Date  ICMJE November 14, 2023
Last Update Posted Date November 14, 2023
Actual Study Start Date  ICMJE January 28, 2021
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2023)		 Detection of Tumor Necrosis Post-chemotherapy [ Time Frame: 12 weeks ]
Participants will be assessed with 18F FTC 146 PET/CT imaging at baseline and after neoadjuvant (pre surgery) chemotherapy but before surgery itself. Chemotherapy will be nominally three 3 week cycles administered over up to 12 weeks. The ability of 18F FTC 146 PET/CT to evaluate treatment effect will be assessed as the percentage of tumor that is assessed as necrotic after the treatment course. The outcome will be reported as the mean percentage of the resected tumor (removed by surgery) that is assessed by histopathology as necrotic, with standard deviation.
Original Primary Outcome Measures  ICMJE
 (submitted: April 24, 2020)		 Detection of tumor necrosis post-chemotherapy [ Time Frame: 12 weeks ]
Participants will be assessed with 18F FTC 146 PET/CT imaging at baseline and after neoadjuvant (pre surgery) chemotherapy but before surgery itself. Chemotherapy will be nominally three 3 week cycles administered over up to 12 weeks. The ability of 18F FTC 146 PET/CT to evaluate treatment effect will be assessed as the percentage of tumor that is assessed as necrotic after the treatment course. The outcome will be reported as the mean percentage of the resected tumor (removed by surgery) that is assessed by histopathology as necrotic, with standard deviation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2020)
  • Maximum Standardized Uptake Value (SUVmax) [ Time Frame: 12 weeks ]
    Participants will be assessed with 18F FTC 146 PET/CT imaging at baseline and after neoadjuvant (pre surgery) chemotherapy but before surgery itself. Chemotherapy will be nominally three 3 week cycles administered over up to 12 weeks. Based on the PET/CT scans, the maximum standardized uptake value (SUVmax) in the tumor region of interest (ROI) will be calculated at baseline and after treatment. The outcome will be reported as the mean percent change in SUVmax from baseline to post treatment, with standard deviation.
  • Use of Patient Reported Outcomes Measurement Information System (PROMIS) to Assess Treatment Effect [ Time Frame: 12 weeks ]
    Participants will receive neoadjuvant (pre surgery) chemotherapy, nominally three 3 week cycles administered over up to 12 weeks. The treatment effect of the neoadjuvant chemotherapy will be assessed as the change in scores on the PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire, from baseline to post treatment. The result will be reported as the mean difference from baseline to post treatment, with standard deviation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma
Official Title  ICMJE A Phase 2 Study of 18F FTC 146 PET/CT in Patients With Newly Diagnosed Osteosarcoma
Brief Summary The purpose of this research is to evaluate the study drug, 18F FTC-146, as a positron emission tomography (PET) / computed tomography (CT) radiotracer imaging agent to evaluate tumor status in patients newly diagnosed with osteosarcoma ("bone cancer").
Detailed Description

Primary Objective: Demonstrate correlation of pre-post reduction in 18F-FTC-146 PET/CT with amount of post-treatment tumor necrosis in newly-diagnosed and treated osteosarcoma patients.

Secondary Objective: Demonstrate correlation of pre-post reduction in 18F-FTC-146 PET/CT with amount of post-treatment pain reduction in newly-diagnosed and treated osteosarcoma patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Osteosarcoma
Intervention  ICMJE Drug: 18-F FTC 146
Radiotracer, 10 mCi at pre- and post- chemotherapy, intravenous administration
Study Arms  ICMJE Experimental: 18-F-FTC 146 PET/CT
For PET scans, subjects will receive intravenous injection of 10 mCi 18-F -FTC 146 administered twice with 18-F-FTC 146, once at baseline (pre chemotherapy) and once at final study visit (post chemotherapy).
Intervention: Drug: 18-F FTC 146
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 10, 2022)		 1
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2020)		 5
Actual Study Completion Date  ICMJE July 22, 2021
Actual Primary Completion Date May 28, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with biopsy proven osteosarcoma requiring local surgical intervention.
  • ECOG ≤ 2
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Chemotherapy in the past 2 months.
  • Prior history of allergic reaction to 18F FTC 146.
  • Pregnant or nursing
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04365660
Other Study ID Numbers  ICMJE IRB-52746
SARCOMA0041 ( Other Identifier: OnCore )
IRB-52746 ( Other Identifier: Stanford IRB )
NCI-2021-03443 ( Registry Identifier: CTRP )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kristen Ganjoo, Stanford University
Original Responsible Party Stanford University
Current Study Sponsor  ICMJE Davidzon, Guido, M.D.
Original Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristen N Ganjoo Stanford Universiy
PRS Account Stanford University
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP