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Imaging and Biospecimen Collection for Acute Myeloid Leukemia

Q: Are there any historical precedents of exploration into Fluorothymidine F-18?

Presently, there are 4 clinical trials taking place that investigate Fluorothymidine F-18. None of these active tests have advanced to phase 3 yet, although <a href="https://www.withpower.com/clinical-trials/all">all</a> the studies for this treatment originate from Duarte, <a href="https://www.withpower.com/clinical-trials/california">California</a> and a total of 4 sites worldwide are running them.

Q: How many participants is the clinical trial limited to?

Affirmative. Clinicaltrials.gov data reveals that this research is currently seeking participants, with its initial posting dating back to February 15th 2018 and the latest edit being November 12th 2022. It needs 74 volunteers from one site in particular.

Q: Is it still possible to take part in this experiment?

Affirmative. According to clinicaltrials.gov, this research is still in need of subjects; the trial having been first published on February 15th 2018 and last updated November 12th 2022. 74 volunteers are required from a single location for the project's completion.

Phase < 1

Recruiting

Led By Jeffrey Y Wong

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cohort TBI: Patients who have not received a prior transplant

Cohort TBI: First or second remission AML or ALL patients that will receive TBI (13.2 Gy) plus chemotherapy (etoposide [VP16] 60 mg/kg or cyclophosphamide [Cy] 60 mg/kg for two days) as part of their standard of care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial investigates how TBI and chemotherapy affects bone marrow by looking at changes via imaging and collecting patient samples.

Who is the study for?

This trial is for adults aged 18-60 with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), who are in their first or second remission and haven't had a prior transplant. They must be eligible for certain other studies, consent to participate, and agree to undergo specific imaging if enrolling on COH 14012 or IRB 17505.Check my eligibility

What is being tested?

The study is examining how total body irradiation (TBI) combined with chemotherapy affects bone marrow changes in AML/ALL patients. It involves advanced imaging techniques like Dual-Energy CT, MRI, PET scans using Fluorothymidine F-18, and collecting biospecimen samples.See study design

What are the potential side effects?

Potential side effects may include reactions related to the imaging agents used such as allergic reactions or discomfort at the injection site. Chemotherapy and TBI can cause fatigue, nausea, hair loss, infection risk increase, bleeding complications, and damage to organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have never had a transplant before.

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I have AML or ALL in first or second remission and will get TBI with chemotherapy as standard care.

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I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change over time in cellularity and adiposity

Change over time of red marrow (cellularity) and yellow marrow (adipocyte)

Hematopoietic stem cell density in bone marrow biopsy samples (sub-analysis)

+3 more

Secondary outcome measures

Blast counts

Change in FLT PET activity

SUV distribution and presence of focal hot spot

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cohort I (TMLI+FLT/TMLI)Experimental Treatment6 Interventions

Patients may undergo optional fluorothymidine F-18 PET scan over 2 hours at baseline, on days 30 and 100, at 1 year, and at time of relapse. Patients undergo DECT and water-fat MRI scan over 30 minutes at baseline, on days 30 and 100, at year 1, and at time of relapse. Patients also undergo collection of bone marrow and blood samples at baseline, on days 30 and 100, and at 1 year. Patients undergo fluorothymidine F-18 PET, DECT, and water-fat MRI as in TMLI+FLT.

Group II: Cohort II (TBI)Active Control2 Interventions

Patients undergo collection of bone marrow at baseline, day 30, time of relapse, and at 1 year.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dual-Energy Computed Tomography

2018

N/A

~50

Fluorothymidine F-18

2003

Completed Phase 2

~180

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

Biospecimen Collection

2004

Completed Phase 2

~1700

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,586 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,667 Previous Clinical Trials

40,926,058 Total Patients Enrolled

Jeffrey Y WongPrincipal InvestigatorCity of Hope Comprehensive Cancer Center

8 Previous Clinical Trials

151 Total Patients Enrolled

Media Library

Fluorothymidine F-18 Clinical Trial Eligibility Overview. Trial Name: NCT03422731 — Phase < 1

Acute Lymphoblastic Leukemia Research Study Groups: Cohort I (TMLI+FLT/TMLI), Cohort II (TBI)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Fluorothymidine F-18 Highlights & Side Effects. Trial Name: NCT03422731 — Phase < 1

Fluorothymidine F-18 2023 Treatment Timeline for Medical Study. Trial Name: NCT03422731 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any historical precedents of exploration into Fluorothymidine F-18?

"Presently, there are 4 clinical trials taking place that investigate Fluorothymidine F-18. None of these active tests have advanced to phase 3 yet, although all the studies for this treatment originate from Duarte, California and a total of 4 sites worldwide are running them."

Answered by AI

How many participants is the clinical trial limited to?

"Affirmative. Clinicaltrials.gov data reveals that this research is currently seeking participants, with its initial posting dating back to February 15th 2018 and the latest edit being November 12th 2022. It needs 74 volunteers from one site in particular."

Answered by AI

Is it still possible to take part in this experiment?

"Affirmative. According to clinicaltrials.gov, this research is still in need of subjects; the trial having been first published on February 15th 2018 and last updated November 12th 2022. 74 volunteers are required from a single location for the project's completion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy

2018. "Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Bone Marrow Changes in Patients With Acute Myeloid Leukemia Undergoing TBI and Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03422731.

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