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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Osteosarcoma
Intervention Drug: 18-F FTC 146
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 18-F-FTC 146 PET/CT
Hide Arm/Group Description For PET scans, 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).
Period Title: Overall Study
Started 1
Received PET/CT Scan 0
Completed 0
Not Completed 1
Arm/Group Title 18-F-FTC 146 PET/CT
Hide Arm/Group Description For PET scans, 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).
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
1
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
 100.0%
1.Primary Outcome
Title Detection of Tumor Necrosis Post-chemotherapy
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome measure.
Arm/Group Title 18-F-FTC 146 PET/CT
Hide Arm/Group Description:
For PET scans, 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).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Maximum Standardized Uptake Value (SUVmax)
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome measure.
Arm/Group Title 18-F-FTC 146 PET/CT
Hide Arm/Group Description:
For PET scans, 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).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Use of Patient Reported Outcomes Measurement Information System (PROMIS) to Assess Treatment Effect
Hide Description 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.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
No data were collected for this outcome measure.
Arm/Group Title 18-F-FTC 146 PET/CT
Hide Arm/Group Description:
For PET scans, 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).
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 18-F-FTC 146 PET/CT
Hide Arm/Group Description For PET scans, 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).
All-Cause Mortality
18-F-FTC 146 PET/CT
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Serious Adverse Events
18-F-FTC 146 PET/CT
Affected / at Risk (%)
Total   0/1 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
18-F-FTC 146 PET/CT
Affected / at Risk (%)
Total   0/1 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kristen Ganjoo, MD
Organization: Stanford University
Phone: 650-498-6000
EMail: kganjoo@stanford.edu
Layout table for additonal information
Responsible Party: Kristen Ganjoo, Stanford University
ClinicalTrials.gov Identifier: NCT04365660    
Other Study ID Numbers: IRB-52746
SARCOMA0041 ( Other Identifier: OnCore )
IRB-52746 ( Other Identifier: Stanford IRB )
NCI-2021-03443 ( Registry Identifier: CTRP )
First Submitted: April 24, 2020
First Posted: April 28, 2020
Results First Submitted: September 28, 2023
Results First Posted: November 14, 2023
Last Update Posted: November 14, 2023