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Trial Outcomes & Findings for Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer (NCT NCT01774760)

NCT ID: NCT01774760

Last Updated: 2019-10-04

Results Overview

Standardized Uptake Values (SUV) are determined in the acquisition images of the \[18F\]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline and 7 days (ie time between the two scans)

Results posted on

2019-10-04

Participant Flow

11 were recruited, 10 started and completed

1 patient withdrawn because of a negative FDG PET scan

Participant milestones

Participant milestones
Measure
18F-EF5 PET/CT Scan
18F-EF5 Pretreatment PET/CT-scan (performed two times)
Overall Study
STARTED
10
Overall Study
COMPLETED
10
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
18F-EF5 PET/CT Scan
n=10 Participants
10 pts with HNSCC. See Table 1 (p. 163) in Eur J Nucl Med Mol Imaging 2018;45:161-169 https://doi.org/10.1007/s00259-017-3857-3
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
Age, Categorical
>=65 years
7 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
10 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
Finland
10 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 7 days (ie time between the two scans)

Population: Head and neck squamous cell carcinoma

Standardized Uptake Values (SUV) are determined in the acquisition images of the \[18F\]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means

Outcome measures

Outcome measures
Measure
Patients With Stage III-IV Head and Neck Cancer
n=10 Participants
Patients undergoing radiation treatment planning who receive pretreatment PET/CT-scan twice within 1 week as an experimental procedure
Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)
1.49 SUVmax
Standard Deviation 0.16

Adverse Events

18F-EF5 PET/CT Scan

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Heikki Minn

Turku University Hospital, Turku, Finland

Phone: +35823130000

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place