[18F] F-GLN by PET/CT in Breast Cancer
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | March 2019 |
| End Date: | December 2024 |
| Contact: | Theresa E Berger, MBE |
| Email: | theresa.berger@uphs.upenn.edu |
| Phone: | 215-746-2813 |
Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer
Patients with known or suspected primary or metastatic breast cancer with one lesion that is
1.5 cm in diameter or greater may be eligible for this study. Patients may participate in
this study if they are at least 18 years of age. Up to 30 evaluable subjects will participate
in a single imaging cohort. Patients will be stratified by breast cancer subtype with
prioritization to recruit at least 10 estrogen-receptor-expressing (ER+) and 10
triple-negative breast cancers (TNBC).
This is an observational study; [18F]F-GLN PET/CT will not be used to direct treatment
decisions. While patients and referring physicians will not be blinded to the [18F]F-GLN
PET/CT results, treatment decisions are made by the treating physicians based upon clinical
criteria.
[18F]F-GLN PET/CT imaging sessions will include an injection of [18F]F-GLN. Metabolism data
will be collected. Pilot data will be collected to evaluate image quality and collect
preliminary information on the uptake of [18F]F-GLN in breast cancer. Uptake measures will be
compared to tumor markers of glutamine metabolism, when tissue is available. The safety of
[18F]F-GLN will also be evaluated in all subjects.
1.5 cm in diameter or greater may be eligible for this study. Patients may participate in
this study if they are at least 18 years of age. Up to 30 evaluable subjects will participate
in a single imaging cohort. Patients will be stratified by breast cancer subtype with
prioritization to recruit at least 10 estrogen-receptor-expressing (ER+) and 10
triple-negative breast cancers (TNBC).
This is an observational study; [18F]F-GLN PET/CT will not be used to direct treatment
decisions. While patients and referring physicians will not be blinded to the [18F]F-GLN
PET/CT results, treatment decisions are made by the treating physicians based upon clinical
criteria.
[18F]F-GLN PET/CT imaging sessions will include an injection of [18F]F-GLN. Metabolism data
will be collected. Pilot data will be collected to evaluate image quality and collect
preliminary information on the uptake of [18F]F-GLN in breast cancer. Uptake measures will be
compared to tumor markers of glutamine metabolism, when tissue is available. The safety of
[18F]F-GLN will also be evaluated in all subjects.
Up to 30 patients will undergo approximately 60 minutes of dynamic PET scanning followed by
up to 2 static skull-base to mid-thigh scans post injection of [18F] (2S,4R)4-fluoroglutamine
([18F]F-GLN). A baseline FDG-PET/CT will also be performed, either as a routine clinical
staging/re-staging scan or as a research scan. If performed as a research scan, the scan may
include an optional dynamic imaging session. Some subjects, who undergo systemic therapy as
part of their clinical treatment, may also undergo an optional second [18F]F-GLN PET/CT to
collect pilot data on the changes in [18F]F-GLN uptake in response to therapy. Subjects who
undergo a second [18F]F-GLN PET/CT may have a second FDG-PET/CT, again either as a
standard-of-care restaging study or as an optional research scan. The timing of the optional
second PET scans will vary depending on the type of treatment the subject is receiving.
up to 2 static skull-base to mid-thigh scans post injection of [18F] (2S,4R)4-fluoroglutamine
([18F]F-GLN). A baseline FDG-PET/CT will also be performed, either as a routine clinical
staging/re-staging scan or as a research scan. If performed as a research scan, the scan may
include an optional dynamic imaging session. Some subjects, who undergo systemic therapy as
part of their clinical treatment, may also undergo an optional second [18F]F-GLN PET/CT to
collect pilot data on the changes in [18F]F-GLN uptake in response to therapy. Subjects who
undergo a second [18F]F-GLN PET/CT may have a second FDG-PET/CT, again either as a
standard-of-care restaging study or as an optional research scan. The timing of the optional
second PET scans will vary depending on the type of treatment the subject is receiving.
Inclusion Criteria:
- Participants will be ≥ 18 years of age
- Known or suspected primary or metastatic breast cancer.
- At least one lesion ≥ 1.5 cm that is seen on standard imaging (e.g. CT, MRI,
mammogram, ultrasound, FDG-PET/CT). Only one type of imaging is required to show a
lesion.
- Participants must be informed of the investigational nature of this study and be
willing to provide written informed consent and participate in this study in
accordance with institutional and federal guidelines prior to study-specific
procedures.
Exclusion Criteria:
- Females who are pregnant or breast feeding at the time of screening; a urine pregnancy
test will be performed in women of child-bearing potential at screening.
- Inability to tolerate imaging procedures in the opinion of an investigator or treating
physician.
- Any current medical condition, illness, or disorder, as assessed by medical record
review and/or self-reported, that is considered by a physician investigator to be a
condition that could compromise participant safety or successful participation in the
study.
We found this trial at
1
site
3451 Walnut St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Austin Pantel, MD
Phone: 215-746-2813
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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