Imaging Apoptosis for Lymphoma Treatment Response

• Status: Not yet recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

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 combination therapies such as rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) used to treat diffuse large B-cell lymphoma (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 newly diagnosed DLBCL being treated with R-CHOP.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: AbbVie

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

• New diagnosis of diffuse large B cell lymphoma (DLBCL) who will be treated with R-CHOP

• At least one measurable (RECIST 1.1), FDG-avid lesion that is accessible for ultrasound guided biopsy.

• 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