Trial Outcomes & Findings for Infiltration Effect on SUV (NCT NCT03320564)

Results Overview

Target lesions selected as per PERCIST criteria. These criteria require more space than allowed to explain. Reference J Nucl Med 2009; 50: 122S-150S. DOI: 10.2967/jnumed.108.057307

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

Baseline scan and follow up scan within 7 days

Results posted on

2022-03-18

Participant Flow

Participant milestones

Participant milestones
Measure	Infiltration Repeat F-18 FDG PET F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Infiltration Repeat F-18 FDG PET F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.
Overall Study Protocol Violation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Infiltration n=1 Participants Repeat F-18 FDG PET F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.
Age, Categorical <=18 years	0 Participants n=1 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants
Age, Categorical >=65 years	1 Participants n=1 Participants
Sex: Female, Male Female	0 Participants n=1 Participants
Sex: Female, Male Male	1 Participants n=1 Participants
Region of Enrollment United States	1 participants n=1 Participants
Initial Lara TAC score	1104 units on a scale STANDARD_DEVIATION NA • n=1 Participants

PRIMARY outcome

Timeframe: Baseline scan and follow up scan within 7 days

Population: Up to 5 target lesions measured per participant (4 for this subject) with mean and standard deviation reported below.

Target lesions selected as per PERCIST criteria. These criteria require more space than allowed to explain. Reference J Nucl Med 2009; 50: 122S-150S. DOI: 10.2967/jnumed.108.057307

Outcome measures

Outcome measures
Measure	Infiltration n=1 Participants Repeat F-18 FDG PET F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.
Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans	3.6 SUV (dimensionless) Standard Deviation 1.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Metabolic tumor volume to be measured using threshold defined in PERCIST criteria

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Total lesion glycolysis is calculated for the same metabolic tumor volume as Outcome 2

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 7 days

Response is defined per PERCIST criteria

Outcome measures

Outcome data not reported

Adverse Events

Infiltration

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Infiltration n=1 participants at risk Repeat F-18 FDG PET F-18 FDG PET: Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hospitalization	100.0% 1/1 • Number of events 1 • All subjects assessed from enrollment to study closure. For the subject with data recorded, approximately 5 months between enrollment and study closure.

Other adverse events

Adverse event data not reported

Additional Information

Katie Holbrook Bingman

Wake Forest Baptist Health

Phone: 336-713-7765

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60