18F-FSPG PET/CT for Cancer Patients on Therapy
Study Details
Study Description
Brief Summary
The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.
Detailed Description
OUTLINE:
Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG [18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before and after therapeutic treatment.
PRIMARY OBJECTIVE:
Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.
SECONDARY OBJECTIVES:
-
Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.
-
Safety and tolerability of 18F-FSPG and 18F-FDG.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 18F-FSPG and 18F-FDG Intragroup Comparision Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. |
Drug: 18F-FSPG
Administered intravenously (IV)
Other Names:
Drug: 18F-FDG
Administered intravenously (IV)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment [Baseline and up to 2 years]
Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
Secondary Outcome Measures
- Number of Treatment-Related Adverse Events [Baseline to up to 2 years]
Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.
- Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs [Baseline and up to 2 years]
Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written informed consent
-
Able to complete a PET/CT scan without the use of sedation
-
Females:
-
Of childbearing potential must:
-
Not be nursing
-
Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT
-
Not of childbearing potential must be:
-
Physiologically postmenopausal (cessation of menses for more than 1 year)
-
Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)
-
Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
-
Scheduled to begin therapy
-
The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)
-
Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion)
-
No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week
Exclusion Criteria:
-
Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration
-
Known sensitivity to 18F FSPG or components of the preparation
-
Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Stanford University Medical Center | Stanford | California | United States | 94304 |
Sponsors and Collaborators
- Andrei Iagaru
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Andrei M Iagaru, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB-31855
- NCI-2015-01125
- VARIMG0006
- P30CA124435
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | 18F-FSPG and 18F-FDG Intragroup Comparision |
---|---|
Arm/Group Description | Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV) |
Period Title: Overall Study | |
STARTED | 7 |
COMPLETED | 7 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | 18F-FSPG and 18F-FDG Intragroup Comparision |
---|---|
Arm/Group Description | Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV) |
Overall Participants | 7 |
Age (Count of Participants) | |
<=18 years |
0
0%
|
Between 18 and 65 years |
2
28.6%
|
>=65 years |
5
71.4%
|
Age (years) [Median (Standard Deviation) ] | |
Median (Standard Deviation) [years] |
69.1
(13.2)
|
Sex: Female, Male (Count of Participants) | |
Female |
3
42.9%
|
Male |
4
57.1%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
0
0%
|
Not Hispanic or Latino |
7
100%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
2
28.6%
|
White |
5
71.4%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
United States |
7
100%
|
Outcome Measures
Title | Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment |
---|---|
Description | Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor. |
Time Frame | Baseline and up to 2 years |
Outcome Measure Data
Analysis Population Description |
---|
Locations (ie, of lesions) that did not produce an SUVmax value either before or after treatment are omitted from the mean. Note that an analysis "mean of differences" would have a dispersion, but an analysis for "difference of means" is simply the delta (a number) between 2 measures of central tendency (mean), and does not have a dispersion. |
Arm/Group Title | 18F-FSPG and 18F-FDG Intragroup Comparision |
---|---|
Arm/Group Description | Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV) |
Measure Participants | 7 |
Measure Lesion locations assessed | 40 |
18F-FSPG |
-1.69
|
18F-FDG |
-0.64
|
Title | Number of Treatment-Related Adverse Events |
---|---|
Description | Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion. |
Time Frame | Baseline to up to 2 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 18F-FSPG and 18F-FDG Intragroup Comparision |
---|---|
Arm/Group Description | Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV) |
Measure Participants | 7 |
18F-FSPG |
0
|
18F-FDG |
0
|
Title | Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs |
---|---|
Description | Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion). |
Time Frame | Baseline and up to 2 years |
Outcome Measure Data
Analysis Population Description |
---|
Lesion locations not detected both before and after treatment are reported as N/A for 2-D area (in the effect that an assessment could be made with the other radiolabel). Lesions detected at either before or after treatment only are reported as the difference from zero. |
Arm/Group Title | Difference in Lesion Size as Detected by 18F-FSPG | Difference in Lesion Size as Detected by 18F-FDG |
---|---|---|
Arm/Group Description | Participants sequentially receive radioimaging agent 18F-FSPG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) | Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FDG: Administered intravenously (IV) |
Measure Participants | 7 | 7 |
Measure Lesion locations assessed | 17 | 26 |
Adrenal / adrenal mass, left |
NA
|
11.3
|
Adrenal / hepatic dome |
NA
|
-2.0
|
Adrenal / liver metastatis |
NA
|
-1.3
|
Adrenal / lung base metastatis, lower lobe right |
NA
|
1.4
|
Adrenal / lung metastatis, left |
NA
|
-0.7
|
Lung / infrascapular subcut |
0.2
|
NA
|
Lung / abdominal wall, upper quadrant right |
7.6
|
6.9
|
Lung / adajcent subcarinal lymph node |
NA
|
3.0
|
Lung / aortopulmonary window lymph node |
-1.1
|
-2.8
|
Lung / hilar lymph node, left |
NA
|
-2.3
|
Lung / infraspinatus mm, right |
10.4
|
10.2
|
Lung / lingula nodule |
-1.7
|
-2.7
|
Lung / mass, upper lobe left |
-8.1
|
-6.4
|
Lung / mass, lower lobe right |
NA
|
-14.5
|
Lung / nodule 1, lower lobe right |
NA
|
-0.8
|
Lung / nodule 2, upper lobe right |
-1.7
|
-1.5
|
Lung / nodule, upper lobe right |
NA
|
-0.4
|
Lung / paraesophageal lymph node |
0.9
|
NA
|
Lung / post-basal, lower lobe right |
NA
|
-3.6
|
Lung / subcarinal lymph node |
1.4
|
11.4
|
Renal / adrenal mass, right |
3.1
|
7.1
|
Renal / aortopulmonary window lymph node, left |
1.1
|
-1.2
|
Renal / gluteal subcutaneous nodule |
0.2
|
0.2
|
Renal / interlobar |
2.4
|
NA
|
Renal / kidney midpole, right |
-1.2
|
-1.4
|
Renal / omental nodule |
-0.2
|
1.2
|
Renal / paratracheal lymph node, right |
0.6
|
-2.0
|
Renal / parotid, right |
NA
|
-2.3
|
Renal / retroperitoneal lymph node, left |
1.6
|
2.2
|
Adverse Events
Time Frame | 30 days | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | 18F-FSPG and 18F-FDG Intragroup Comparision | |
Arm/Group Description | Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes. 18F-FSPG: Administered intravenously (IV) 18F-FDG: Administered intravenously (IV) | |
All Cause Mortality |
||
18F-FSPG and 18F-FDG Intragroup Comparision | ||
Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | |
Serious Adverse Events |
||
18F-FSPG and 18F-FDG Intragroup Comparision | ||
Affected / at Risk (%) | # Events | |
Total | 0/7 (0%) | |
Other (Not Including Serious) Adverse Events |
||
18F-FSPG and 18F-FDG Intragroup Comparision | ||
Affected / at Risk (%) | # Events | |
Total | 1/7 (14.3%) | |
Metabolism and nutrition disorders | ||
Elevated blood ammonia | 1/7 (14.3%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Andrei H. Iagaru |
---|---|
Organization | Stanford University |
Phone | (650) 725-4711 |
aiagaru@stanford.edu |
- IRB-31855
- NCI-2015-01125
- VARIMG0006
- P30CA124435