Imaging Apoptosis for Lymphoma Treatment Response

NCT ID: NCT05048732

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-06
• Study Completion Date: 2024-02-10

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.

Conditions

Diffuse Large B Cell Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cohort 1 = Healthy Volunteers

• Healthy volunteers (N=6, three male, three female) will be recruited to undergo a single 18F-FAT PET/CT imaging session for radiation dosimetry estimates.
• 18F-FAT administration followed by body imaging at 3 time points

• 0-60 min = multiple quick body scans
• 120 min post injection = body scan
• 240 min post injection = body scan

Group Type: EXPERIMENTAL

18F-FluorApoTrace

Intervention Type: DRUG

-The dose of 18F-FluorApoTrace to be given is 5 mCi

Cohort 2a: Newly Diagnosed DLBCL patients being treated with R-CHOP

-N= 6 : 18F-FAT imaging session at baseline and Day 2-4 following Cycle 1 standard of care therapy.

Group Type: EXPERIMENTAL

18F-FluorApoTrace

Intervention Type: DRUG

-The dose of 18F-FluorApoTrace to be given is 5 mCi

Cohort 2b: Newly Diagnosed DLBCL patients being treated with R-CHOP

-N=9: 18F-FAT imaging session at baseline and best time point determined from Cohort 2a (2 days post Cycle 1 standard of care therapy)

Group Type: EXPERIMENTAL

18F-FluorApoTrace

Intervention Type: DRUG

-The dose of 18F-FluorApoTrace to be given is 5 mCi

Interventions

18F-FluorApoTrace

-The dose of 18F-FluorApoTrace to be given is 5 mCi

Intervention Type: DRUG

Other Intervention Names

18F-FAT

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Farrokh Dehdashti, M.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

202108112

Identifier Type: -

Identifier Source: org_study_id