Malignant NeoplasmNCT02888301
18F-Clofarabine PET/CT in Imaging Cancer Patients Before and After Interventions
An observational study of Malignant Neoplasm, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed tomography (CT) in imaging patients with cancer before and after treatment with a therapy that activates the patient's immune system (immunotherapy). PET/CT scans give detailed pictures of areas inside the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm
- What is being tested?
- Computed Tomography, Fluorine F 18 Clofarabine and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2015to 30 Apr 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult cancer patients under treatment using immune system activating interventions.
Who may be able to join
- Must be able to tolerate PET/CT (i.e. not claustrophobic and able to remain supine)
- No restrictions based on gender or racial/ethnic background
Who cannot join
- Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: The Biodistribution of [18F]-Clofarabine in Cancer Patients Before and After Interventions That Increase the Activity of Deoxycytidine Kinase
This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed tomography (CT) in imaging patients with cancer before and after treatment with a therapy that activates the patient's immune system (immunotherapy). PET/CT scans give detailed pictures of areas inside the body. 18F-clofarabine is a drug that contains a radioactive substance that is taken up by cells expressing deoxycytidine kinase (dCK), which is highly expressed in activated immune cells, making them light up during PET/CT scans. Doctors also want to know how 18F-clofarabine is distributed throughout the body before and after treatment with immunotherapies.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether positron emission tomography (PET) using the new imaging agent 18F-clofarabine can be used for imaging cancer, and whether interventions that activate the immune system can change the biodistribution of 18F-clofarabine.
OUTLINE:
Patients receive 18F-clofarabine intravenously (IV) and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.
- Conditions
- Malignant Neoplasm
- Being tested
- Computed Tomography, Fluorine F 18 Clofarabine, Positron Emission Tomography
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography
Undergo 18F-clofarabine PET/CT
Fluorine F 18 ClofarabineRadiation
Also called 18F-CA, 18F-Clofarabine, [18F]-Clofarabine, Cl-18F-ara-A
Given IV
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan
Undergo 18F-clofarabine PET/CT
| Study group | Role | What they receive |
|---|---|---|
| Basic science (18F-clofarabine biodistribution) | Patients receive 18F-clofarabine IV and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy. Receives: Procedure: Computed Tomography; Radiation: Fluorine F 18 Clofarabine; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-clofarabine concentration in cancer tissue
Measured: Up to 4 weeks
Change in 18F-clofarabine biodistribution
For the biodistribution studies, regions of interest will be drawn on images of liver, kidney, bladder, heart, lung and blood pool to obtain regional activity count rates. Standardized uptake values (SUV = count activity per ml within region of interest (MBq-1)/(injected dose [MBq]/body weight [kgx1000]) will be calculated for different organs and for regions of tumor. Further, regional target to background count activity ratios will be established.
Measured: Baseline to up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start12 Jun 2015
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Allen-Auerbach, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888301
- Sponsor's protocol ID
- 15-000246
- Other IDs
- NCI-2016-00210, 15-000246
- Status last verified
- Feb 2019
- First submitted
- 30 Aug 2016
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Biodistribution of [18F]-Clofarabine in Cancer Patients Before and After Interventions That Increase the Activity of Deoxycytidine Kinase
- ClinicalTrials.gov ID
- NCT02888301
- Acronym / sponsor ID
- 15-000246
- Conditions
- Malignant Neoplasm
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Jun 2015 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies 18F-clofarabine positron emission tomography (PET)/computed tomography (CT) in imaging patients with cancer before and after treatment with a therapy that activates the patient's immune system (immunotherapy). PET/CT scans give detailed pictures of areas inside the body. 18F-clofarabine is a drug that contains a radioactive substance that is taken up by cells expressing deoxycytidine kinase (dCK), which is highly expressed in activated immune cells, making them light up during PET/CT scans. Doctors also want to know how 18F-clofarabine is distributed throughout the body before and after treatment with immunotherapies.
Detailed description
PRIMARY OBJECTIVES:
- To determine whether positron emission tomography (PET) using the new imaging agent 18F-clofarabine can be used for imaging cancer, and whether interventions that activate the immune system can change the biodistribution of 18F-clofarabine.
OUTLINE:
Patients receive 18F-clofarabine intravenously (IV) and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Basic science (18F-clofarabine biodistribution) | – | Procedure: Computed Tomography, Radiation: Fluorine F 18 Clofarabine, Procedure: Positron Emission TomographyPatients receive 18F-clofarabine IV and undergo PET/CT scan at baseline and 2-4 weeks after completion of immunotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients under treatment using immune system activating interventions.
Key inclusion criteria (2 listed)
- Must be able to tolerate PET/CT (i.e. not claustrophobic and able to remain supine)
- No restrictions based on gender or racial/ethnic background
Key exclusion criteria (1 listed)
- Women of childbearing age will have to undergo a pregnancy test that will be provided free of charge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computerized Axial Tomography, Computerized TomographyUndergo 18F-clofarabine PET/CT | Procedure or surgery | Basic science (18F-clofarabine biodistribution) |
| Fluorine F 18 ClofarabineAlso: 18F-CA, 18F-Clofarabine, [18F]-Clofarabine, Cl-18F-ara-AGiven IV | Radiation | Basic science (18F-clofarabine biodistribution) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography ScanUndergo 18F-clofarabine PET/CT | Procedure or surgery | Basic science (18F-clofarabine biodistribution) |
Primary outcome
18F-clofarabine concentration in cancer tissue
Time frame: Up to 4 weeks
Change in 18F-clofarabine biodistribution
Time frame: Baseline to up to 4 weeks
For the biodistribution studies, regions of interest will be drawn on images of liver, kidney, bladder, heart, lung and blood pool to obtain regional activity count rates. Standardized uptake values (SUV = count activity per ml within region of interest (MBq-1)/(injected dose [MBq]/body weight [kgx1000]) will be calculated for different organs and for regions of tumor. Further, regional target to background count activity ratios will be established.
Results and safety
The study was stopped early (reason given: slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Allen-Auerbach principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Neoplasm, run by Jonsson Comprehensive Cancer Center 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 2 inclusion and 1 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 12 Aug 2020. 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.
Are results available for this study?
The study was stopped early (reason given: slow accrual). 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?
18F-clofarabine concentration in cancer tissue (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2020.