Trial Outcomes & Findings for [18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients (NCT NCT04678440)

Last Updated: 2025-07-02

Results Overview

Data on \[18F\]F-AraG uptake in several tissue types will be collected from healthy subjects. This data will be presented in the form of time-activity curves (TAC) generated for each tissue type. Quantitative assessment of \[18F\]F-AraG biodistribution in healthy tissues will be reported as a function of time as mean Standard Uptake Value (SUV)

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

5 participants

Primary outcome timeframe

Baseline

Results posted on

2025-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Volunteers Study participants will undergo a single dynamic \[18F\]F-AraG PET/CT scan (of duration up to 90-minutes) on the uEXPLORER PET/CT scanner. There will be a follow-up visit or call 7 days after the scan to assess any adverse events that could be attributed to either the scan or the administration of \[18F\]F-AraG. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG	Non-Small Cell Lung Cancer Patients (NSCLC) Study participants with NSCLC who are planned to receive PD-1/PD-L1 immunotherapy will undergo a pre-therapy dynamic \[18F\]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic \[18F\]F-AraG PET/CT scan on the uEXPLORER total-body scanner. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG
Overall Study STARTED	4	1
Overall Study COMPLETED	4	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

[18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline

Population: This outcome measure is only measured in the healthy subjects.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=4 Participants Study participants will undergo a single dynamic \[18F\]F-AraG PET/CT scan (of duration up to 90-minutes) on the uEXPLORER PET/CT scanner. There will be a follow-up visit or call 7 days after the scan to assess any adverse events that could be attributed to either the scan or the administration of \[18F\]F-AraG. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG	Non-Small Cell Lung Cancer Patients (NSCLC) - Pre-Therapy Scan Study participants with NSCLC who are planned to receive PD-1/PD-L1 immunotherapy will undergo a pre-therapy dynamic \[18F\]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic \[18F\]F-AraG PET/CT scan on the uEXPLORER total-body scanner. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG	Non-Small Cell Lung Cancer Patients (NSCLC) - 7 to 14 Days Post Therapy Study participants with NSCLC who are planned to receive PD- 1/PD-L1 immunotherapy will undergo a pre-therapy dynamic \[18F\]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic \[18F\]F-AraG PET/CT scan on the EXPLORER total-body scanner. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Blood Pool	0.31 SUV Standard Deviation 0.01	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Myocardium	4.36 SUV Standard Deviation 0.27	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Brain	0.04 SUV Standard Deviation 0.01	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Kidney	32.88 SUV Standard Deviation 5.42	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Liver	16.05 SUV Standard Deviation 2.03	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Spleen	3.46 SUV Standard Deviation 0.41	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Muscle	1.05 SUV Standard Deviation 0.26	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Lungs	0.67 SUV Standard Deviation 0.12	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Bone Marrow	1.46 SUV Standard Deviation 0.23	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Physiologic Uptake in Various Healthy Tissues Lymph Nodes	1.57 SUV Standard Deviation 0.51	—	—

PRIMARY outcome

Timeframe: Baseline and 7-14 days after first dose of PD-1/PD-L1

Population: Mean and standard deviations are reported across seven different tumor sites and four different lymph nodes.

Data on \[18F\]F AraG uptake in tumor lesions and background activity in the same tissues as in Outcome 1 will be collected. This data will be similarly presented in the form of time-activity curves (TAC) generated for each tissue type, as well as for tumor lesions against their background tissues.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=1 Participants Study participants will undergo a single dynamic \[18F\]F-AraG PET/CT scan (of duration up to 90-minutes) on the uEXPLORER PET/CT scanner. There will be a follow-up visit or call 7 days after the scan to assess any adverse events that could be attributed to either the scan or the administration of \[18F\]F-AraG. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG	Non-Small Cell Lung Cancer Patients (NSCLC) - Pre-Therapy Scan Study participants with NSCLC who are planned to receive PD-1/PD-L1 immunotherapy will undergo a pre-therapy dynamic \[18F\]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic \[18F\]F-AraG PET/CT scan on the uEXPLORER total-body scanner. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG	Non-Small Cell Lung Cancer Patients (NSCLC) - 7 to 14 Days Post Therapy Study participants with NSCLC who are planned to receive PD- 1/PD-L1 immunotherapy will undergo a pre-therapy dynamic \[18F\]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic \[18F\]F-AraG PET/CT scan on the EXPLORER total-body scanner. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG
Data on Whole-body Pharmacokinetics of [18F]F-AraG Pathologic Uptake in Tumor Lesions Relative to Uptake in Background Tissues in NSCLC Subjects Tumor (baseline)	2.14 SUV Standard Deviation 0.20	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Pathologic Uptake in Tumor Lesions Relative to Uptake in Background Tissues in NSCLC Subjects Tumor (after therapy)	2.30 SUV Standard Deviation 0.54	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Pathologic Uptake in Tumor Lesions Relative to Uptake in Background Tissues in NSCLC Subjects Mediastinal Lymph Nodes (Baseline)	2.54 SUV Standard Deviation 0.69	—	—
Data on Whole-body Pharmacokinetics of [18F]F-AraG Pathologic Uptake in Tumor Lesions Relative to Uptake in Background Tissues in NSCLC Subjects Mediastinal Lymph Nodes (after therapy)	3.15 SUV Standard Deviation 0.58	—	—

PRIMARY outcome

Timeframe: Baseline and 7-14 days after first dose of PD-1/PD-L1

We will calculate the tumor-to-background Standardized Uptake Value Ratio (SUVR) at multiple time points. The primary aim is to identify the earliest time at which the SUVR indicates adequate tumor uptake relative to non-malignant tissue. This will guide recommendations for the ideal imaging start time for static whole-body scans.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=4 Participants Study participants will undergo a single dynamic \[18F\]F-AraG PET/CT scan (of duration up to 90-minutes) on the uEXPLORER PET/CT scanner. There will be a follow-up visit or call 7 days after the scan to assess any adverse events that could be attributed to either the scan or the administration of \[18F\]F-AraG. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG	Non-Small Cell Lung Cancer Patients (NSCLC) - Pre-Therapy Scan n=1 Participants Study participants with NSCLC who are planned to receive PD-1/PD-L1 immunotherapy will undergo a pre-therapy dynamic \[18F\]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic \[18F\]F-AraG PET/CT scan on the uEXPLORER total-body scanner. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG	Non-Small Cell Lung Cancer Patients (NSCLC) - 7 to 14 Days Post Therapy n=1 Participants Study participants with NSCLC who are planned to receive PD- 1/PD-L1 immunotherapy will undergo a pre-therapy dynamic \[18F\]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic \[18F\]F-AraG PET/CT scan on the EXPLORER total-body scanner. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Myocardium	13.72 SUV to blood ratio (SUVR) Standard Deviation 0.75	16.9 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	12.3 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Brain	0.13 SUV to blood ratio (SUVR) Standard Deviation 0.03	0.07 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	0.06 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Kidney	109.55 SUV to blood ratio (SUVR) Standard Deviation 28.88	133.0 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	150.2 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Liver	54.75 SUV to blood ratio (SUVR) Standard Deviation 12.38	76.5 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	67.4 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Spleen	11.60 SUV to blood ratio (SUVR) Standard Deviation 1.73	11.7 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	10.2 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Muscle	3.04 SUV to blood ratio (SUVR) Standard Deviation 0.20	3.93 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	1.90 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Lungs	1.83 SUV to blood ratio (SUVR) Standard Deviation 0.37	1.65 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	1.76 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Bone Marrow	4.87 SUV to blood ratio (SUVR) Standard Deviation 1.04	4.41 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	4.11 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Mediastinal Lymph Nodes	5.68 SUV to blood ratio (SUVR) Standard Deviation 1.33	8.59 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	9.50 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject
Tumor-to-Background SUVR Over Time to Determine Earliest Adequate Uptake Tumor	NA SUV to blood ratio (SUVR) Standard Deviation NA No tumors in normal subjects	4.79 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject	6.02 SUV to blood ratio (SUVR) Standard Deviation NA Only 1 subject

Adverse Events

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Small Cell Lung Cancer Patients (NSCLC)

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

Simon Cherry

University of California Davis

Phone: (530) 754-9419

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Healthy Volunteers n=4 Participants Study participants will undergo a single dynamic \[18F\]F-AraG PET/CT scan (of duration up to 90-minutes) on the uEXPLORER PET/CT scanner. There will be a follow-up visit or call 7 days after the scan to assess any adverse events that could be attributed to either the scan or the administration of \[18F\]F-AraG. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG	Non-Small Cell Lung Cancer Patients (NSCLC) n=1 Participants Study participants with NSCLC who are planned to receive PD-1/PD-L1 immunotherapy will undergo a pre-therapy dynamic \[18F\]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic \[18F\]F-AraG PET/CT scan on the uEXPLORER total-body scanner. \[18F\]F-AraG Imaging: Total body PET imaging using \[18F\]F-AraG	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 46 • n=5 Participants	53 years STANDARD_DEVIATION 0 • n=7 Participants	55 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants