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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03863457




Registration number
NCT03863457
Ethics application status
Date submitted
27/02/2019
Date registered
5/03/2019
Date last updated
1/10/2024

Titles & IDs
Public title
[18F] F-GLN by PET/CT in Breast Cancer
Scientific title
Pilot Study Evaluating the Uptake of [18F] F-GLN by PET/CT in Breast Cancer
Secondary ID [1] 0 0
831804
Universal Trial Number (UTN)
Trial acronym
[18F]F-GLN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fluoroglutamine [18F]F-GLN

Experimental: UPTAKE OF [18F]F-GLN BY PET/CT IN BREAST CANCER - 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.


Treatment: Drugs: Fluoroglutamine [18F]F-GLN
Evaluate the kinetics and biodistribution of \[18F\]F-GLN in primary and metastatic breast cancer.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kinetics and Biodistribution of [18F]F-GLN
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Incidence of Adverse Events (Safety and Tolerability)
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Association of Uptake with [18F]F-GLN
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Association with Tumor Markers and [18F]F-GLN
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Metabolism of [18F]F-GLN
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Change in Uptake of [18F]F-GLN After Therapy
Timepoint [5] 0 0
3 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Other
Name
Abramson Cancer Center at Penn Medicine
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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 40 evaluable subjects will participate in a single imaging cohort. Patients will be stratified for analysis 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.
Trial website
https://clinicaltrials.gov/study/NCT03863457
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Austin Pantel, MD
Address 0 0
Instructor of Radiology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Erin Schubert
Address 0 0
Country 0 0
Phone 0 0
215-573-6569
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03863457