Clinical trial NCT05048732: Imaging Apoptosis for Lymphoma Treatment Response
Official title: Imaging Apoptosis for Lymphoma Treatment Response
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Diffuse Large B Cell Lymphoma
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2021-09-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: Apoptosis is a specific form of cell death that leads to clearance of dead cells without causing inflammation or injury to normal adjacent tissues. Targeted cancer therapeutics that target this pathway for tumor cell death induction are in development, but few specific biomarkers of apoptosis are available to assess treatment response. Apoptosis also occurs in response to standard anthracycline or combination therapies such as rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP), rituximab, etoposide, phosphate, prednisone, vincristine sulfacte, cyclophosphamide, and doxorubicin hydrocholoride (R-EPOCH) used to treat many different histopathological types of lymphoma including Hodgkin and non- Hodgkin lymphoma such as diffuse large B-cell lymphoma (DLBCL), Burkitts lymphoma, primary mediastinal B-cell lymphoma and double hit DLBCL. Caspase-3 activation occurs as a result of apoptosis and may be a specific marker of apoptosis. Therefore, this study will assess whether 18F-FluorApoTrace (18F-FAT), a caspase-3 targeted tracer, has a reasonable dosimetry profile and can be used to detect apoptosis in patients with lymphoma being treated with standard therapy.


Eligibility criteria: Inclusion Criteria (Healthy Volunteers):

* Adult 18 years of age or older
* No known hematological disorders
* Considered healthy based on assessment by Principal Investigator (PI).
* Able to provide informed consent
* Able to comprehend and willing to follow instructions for study procedures as called for by the protocol.
* Capable of lying still and supine within the PET/CT scanner for up to 1 hour at a time.

Exclusion Criteria (Healthy Volunteers):

* No illicit drug use or other inhaled drug use (including pharmacologic agents, recreational agents or illicit drugs) within the past year per self-reporting mechanisms.
* No history of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions.
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, OR of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 18 F-FAT) is negative

Inclusion Criteria (Participants with Diffuse Large B Cell Lymphoma):

* Men or women 18 years of age or older with a new diagnosis of lymphoma who will be treated with standard of care therapy for curative intent and at least one measurable (RECIST 1.1), FDG-avid lesion. OR recurrent DLBLC with at least one measurable (RECIST 1.1) FDA-avid lesion and a minimum of 12 months since last receiving treatment.
* If applicable at least one FDG avid lesion accessible for biopsy (ultrasound guided preferred)
* Able to provide informed consent
* Able to tolerate standard of care systemic therapy as recommended by referring physician(s).

Exclusion Criteria (Participants with Diffuse Large B Cell Lymphoma):

* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, OR of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 18 F-FAT) is negative
* Not currently enrolled in another study using an investigational drug

Primary outcomes:
measure: Whole body effective dose (in rems) of a 5 mCi injection of 18F-FAT (Cohort 1 only)
timeFrame: Day 1
measure: Radiation doses (rems) to critical organs (Cohort 1 only)
timeFrame: Day 1
measure: Change in mean standard uptake value (SUV) (Cohort 2 only)
timeFrame: Through completion of early interim treatment monitoring scan (estimated to be 14 days)
measure: Change in maximum standard uptake value (SUV) (Cohort 2 only)
timeFrame: Through completion of early interim treatment monitoring scan (estimated to be 14 days)
Secondary outcomes:
measure: Distribution volume ratio (DVR) (Cohort 2 only)
timeFrame: Through completion of early interim treatment monitoring scan (estimated to be 14 days)
measure: Change in percent positive caspase-3 staining (Cohort 2 only)
timeFrame: Baseline and post-treatment (estimated to be 14 days)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Farrokh Dehdashti, M.D.
role: PRINCIPAL_INVESTIGATOR
References: