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Diffuse Large B Cell LymphomaEarly Phase 1NCT05048732

Imaging Apoptosis for Lymphoma Treatment Response

A Early Phase 1 study testing 18F-FluorApoTrace in people with Diffuse Large B Cell Lymphoma, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
18F-FluorApoTrace
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
6 Dec 2021to 10 Feb 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Being tested
18F-FluorApoTrace
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-FluorApoTraceDrug

    Also called 18F-FAT

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

Study groups in NCT05048732
Study groupRoleWhat they receive
Cohort 1 = Healthy VolunteersExperimental* 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
Receives: Drug: 18F-FluorApoTrace
Cohort 2a: Newly Diagnosed DLBCL patients being treated with R-CHOPExperimental-N= 6 : 18F-FAT imaging session at baseline and Day 2-4 following Cycle 1 standard of care therapy.
Receives: Drug: 18F-FluorApoTrace
Cohort 2b: Newly Diagnosed DLBCL patients being treated with R-CHOPExperimental-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)
Receives: Drug: 18F-FluorApoTrace

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Whole body effective dose (in rems) of a 5 mCi injection of 18F-FAT (Cohort 1 only)

    -The time activity curves will be created using all the scans obtained and integrated to determine organ residence times. This data, plus the counts and volumes from urine collection(s) after tracer injection, will then be used to calculate the dosimetry using OLINDA/EXM v1.1. The calculated residence times will be used with the program OLINDA/EXM for 18F and using the adult human (adult female or male) model to calculate the whole body effective dose.

    Measured: Day 1

  2. Radiation doses (rems) to critical organs (Cohort 1 only)

    The time activity curves will be created using all the scans obtained and integrated to determine organ residence times. This data, plus the counts and volumes from urine collection(s) after tracer injection, will then be used to calculate the dosimetry using OLINDA/EXM v1.1. The calculated residence times will be used with the program OLINDA/EXM for 18F and using the adult human (adult female or male) model to calculate the individual organ radiation dose.

    Measured: Day 1

  3. Change in mean standard uptake value (SUV) (Cohort 2 only)

    -30 minutes and 60-90 minutes post pre-treatment baseline monitoring scan and 30 minutes and 60-90 minutes post early interim treatment monitoring scan

    Measured: Through completion of early interim treatment monitoring scan (estimated to be 14 days)

  4. Change in maximum standard uptake value (SUV) (Cohort 2 only)

    -30 minutes and 6-90 minutes post pre-treatment baseline monitoring scan and 30 minutes and 60-90 minutes post early interim treatment monitoring scan

    Measured: Through completion of early interim treatment monitoring scan (estimated to be 14 days)

Secondary outcomes (2)

  1. Distribution volume ratio (DVR) (Cohort 2 only)

    -DVR will be calculated by reference region Logan plot analysis, in the largest (by size) and most FDG-avid (by maximum SUV) lymphoma lesions.

    Measured: Through completion of early interim treatment monitoring scan (estimated to be 14 days)

  2. Change in percent positive caspase-3 staining (Cohort 2 only)

    • Biopsy samples from baseline and post-treatment will be collected. Immunohistochemical analysis will be performed for caspase-3 staining.
    • The preference for the post-treatment biopsy is for the biopsy to be performed on the same day as 18F-FAT imaging with imaging occurring prior to biopsy (either 2 or 4 days after receiving cycle 1 of R-CHOP). However, due to scheduling conflicts biopsy performed 2-7 days after cycle 1 R-CHOP therapy will be allowed.
    • The staining intensity will be assessed semi-quantitatively using a four-point scale (No Signal=0, Mild=1, Moderate=2, Strong=3). The percentage of stained cells at each intensity level will also be graded typically as 0 (<5%), 1 (5-25%), 2 (26-50%), 3 (51-75%), and 4 (>75%). The intensity score and percentage of positive cells will be then added to produce the final scores (0-7).

    Measured: Baseline and post-treatment (estimated to be 14 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start6 Dec 2021
  3. Primary completion10 Feb 2024
  4. Study completion10 Feb 2024

Why it stopped: Futility

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05048732
Sponsor's protocol ID
202108112
Status last verified
May 2024
First submitted
8 Sep 2021
Last updated
30 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 18F-FluorApoTrace in people with Diffuse Large B Cell Lymphoma, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Futility). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Whole body effective dose (in rems) of a 5 mCi injection of 18F-FAT (Cohort 1 only) (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05048732.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.

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