4.2.1 Inclusion Criteria
All participants must meet all the following criteria prior to receiving 18F-Florestyrosine and
undergoing imaging:
1. Written and voluntarily given informed consent. Pediatric patients (<18 years of age)
will provide assent along with parental/legal guardian/caregiver consent according to IRB
requirements.
2. Male or female ≥ 3 years of age at the time of consent/assent
3. Diagnosis or clinical suspicion of primary glioma in the brain
4. At the time of Screening have undergone therapy for glioma
5. Indeterminate MRI findings for disease recurrence or progression versus treatment
related changes (pseudoprogression or pseudoresponse) requiring further diagnostic
procedures within 60 days prior to the 18F-Florestyrosine PET imaging.
6. Willing and able to lie still for at least 40 minutes in an enclosed space for the imaging
procedure, or if medically necessary, able to tolerate standard institutions procedures for
sedation and/or anesthesia.
4.2.2 Exclusion Criteria
A participant will be excluded from participation in the program if one or more of the
following criteria are met:
1. Participant cannot be safely scanned due to devices, implants, foreign and/or metallic
objects in or on the body that are not MR compatible, unless a clinical judgement is
made that the participant’s diagnostic needs can instead be met by diversion to 18F Floretyrosine imaging by PET/CT (making the magnetic field compatibility an
irrelevant safety concern).
2. Women who are pregnant or breastfeeding.
3. Women of childbearing potential who are unwilling or unable to use an acceptable
method of contraception to avoid pregnancy for the duration of the program (Day 0 to
Day 2).
4. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic),
that may interfere with the objectives of the program or with the safety or compliance of
the participant, as judged by the Investigator.
5. Mental impairment that may compromise the ability to give informed consent/assent
and comply with the requirements of the program, as judged by the Investigator.
6. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the
date of planned administration of 18F-Floretyrosine.
7. Known hypersensitivity to floretyrosine or tyrosine derivatives.
8. Unable to tolerate the program procedures.
[Exempt] An Expanded Access Program for The Non-invasive Characterization of Glioma or Treatment Related Change Utilizing Fluorine (F-18) Floretyrosine (18F-FET, TLX101-CDx)
Details
18F-Floretyrosine, radiolabeled derivative of the amino acid,
tyrosine. Floretyrosine is a substrate for the Large neutral Amino
Acid Transporter (LAT) 1 and 2 and consequently accumulates in
cells where LAT 1 and 2 are expressed on the cell surface.
Fluorine-18 (F 18) is a β+ emitting radionuclide that enables
positron emission tomography (PET).
Eligibility
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4.2 Participant Eligibility
4.2.1 Inclusion Criteria
All participants must meet all the following criteria prior to receiving 18F-Florestyrosine and
undergoing imaging:
Written and voluntarily given informed consent. Pediatric patients (<18 years of age)
will provide assent along with parental/legal guardian/caregiver consent according to IRB
requirements.
Male or female ≥ 3 years of age at the time of consent/assent
Diagnosis or clinical suspicion of primary glioma in the brain
At the time of Screening have undergone therapy for glioma
Indeterminate MRI findings for disease recurrence or progression versus treatment
related changes (pseudoprogression or pseudoresponse) requiring further diagnostic
procedures within 60 days prior to the 18F-Florestyrosine PET imaging.
Willing and able to lie still for at least 40 minutes in an enclosed space for the imaging
procedure, or if medically necessary, able to tolerate standard institutions procedures for
sedation and/or anesthesia.
4.2.2 Exclusion Criteria
A participant will be excluded from participation in the program if one or more of the
following criteria are met:
Participant cannot be safely scanned due to devices, implants, foreign and/or metallic
objects in or on the body that are not MR compatible, unless a clinical judgement is
made that the participant’s diagnostic needs can instead be met by diversion to 18F Floretyrosine imaging by PET/CT (making the magnetic field compatibility an
irrelevant safety concern).
Women who are pregnant or breastfeeding.
Women of childbearing potential who are unwilling or unable to use an acceptable
method of contraception to avoid pregnancy for the duration of the program (Day 0 to
Day 2).
Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic),
that may interfere with the objectives of the program or with the safety or compliance of
the participant, as judged by the Investigator.
Mental impairment that may compromise the ability to give informed consent/assent
and comply with the requirements of the program, as judged by the Investigator.
Exposure to any experimental diagnostic or therapeutic drug within 30 days from the
date of planned administration of 18F-Floretyrosine.
Known hypersensitivity to floretyrosine or tyrosine derivatives.
Unable to tolerate the program procedures.
4.2.3 Inclusion in the Expanded Access Program
Potential participants will be assessed by the Investigator of participating sites and will be
presented with this program to seek interest in participation. Those patients who show interest
will be provided with the information sheet and will undergo an informed consent and/or
assent procedure according to IRB requirements prior to any assessments being initiated (see
Section 13.2).The visit schedule will be planned according to the SOA (Table 1).
Patients officially enter the Expanded Access Program after providing informed
consent/assent. A screen failure is a consented/assented patient deemed ineligible based on 1
or more eligibility criteria or who has withdrawn consent prior to treatment administration.
Screen failures may be rescreened once. Re-screened participants will receive a new
participant number. When deemed medically necessary for a participant to repeat
dosing/imaging, the participant will need to consent/assent to the additional dose and image
but will maintain their original participant identification number.