Lung DiseaseNCT02204202
PET Assessment of Acute Lung Transplant Rejection
An observational study of Lung Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this research study is to gain understanding of the basic responses of the lungs to inflammation and specifically if there may be a better way to detect graft inflammation using non-invasive methods as well as to determine the effectiveness of immunosuppressive treatment regimens in preventing acute… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Disease
- What is being tested?
- [18F]FDG and [18F]ISO-1
- Type of treatment
- Injection or infusion
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 4 Feb 2017
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient within 7 months of double-lung transplantation and who is scheduled for bronchoscopy with biopsy will be eligible. Patients will be identified via the bronchoscopy schedule through the Lung Transplant Center at Barnes-Jewish Hospital / Washington University School of Medicine and approached for potential participation prior to their scheduled bronchoscopy. PET/CT imaging with [18F]FDG will be performed, if consented, no more than 3 days after results from the biopsy are reported. [18F]ISO-1 PET/CT imaging will be performed the day after [18F]FDG PET and can be performed after treatment for acute rejection has been initiated. We intend to image 30 lung transplant recipients with no evidence of rejection (grade A0) and 30 recipients with mild to moderate (grades A2-3) rejection.
Who may be able to join
- Double-lung transplant recipient
- Scheduled for bronchoscopy with transbronchial biopsy
- Capable of lying still and supine with arms raised above the head within the PET/CT scanner for ~1.25 hours
- Capable of following instructions for breathing protocol during CT portion of PET/CT
- Able and willing to give informed consent
- BMI < 35
- Already scheduled to undergo bronchoscopy with bronchoalveolar lavage (BAL) for clinical reasons
- Willing to donate a portion of BAL and biopsy specimen for laboratory testing
Who cannot join
- Glucose level > 150 mg/dl at time of [18F]FDG PET scan (however, up to 160 mg/dl, with repeat testing showing level is stable or decreasing, is acceptable)
- Pregnancy (confirmed by qualitative urine human chorionic gonadotropin (hCG) pregnancy test)
- Lactation
- Presence of implanted electronic medical device
- Enrollment in another research study of an investigational drug
- Inability to lie flat with arms raised above the head for 1.5 hours for PET/CT scans or follow breathing protocol instructions for the CT portion of the PET/CT
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine / Barnes-Jewish Hospital
St Louis, Missouri, 63110
About this study
Official title: Positron Emission Tomography Assessment of Acute Lung Transplant Rejection
The purpose of this research study is to gain understanding of the basic responses of the lungs to inflammation and specifically if there may be a better way to detect graft inflammation using non-invasive methods as well as to determine the effectiveness of immunosuppressive treatment regimens in preventing acute rejection in lung transplant recipients.
Read the detailed description
Positron emission tomography with fluorodeoxyglucose (FDG-PET) is a potential way we can measure lung inflammation. FDG-PET imaging is a clinically accepted and FDA-approved method that is commonly used in the diagnosis and management of cancer. PET is a machine that detects radiation and generates pictures using a donut shaped scanner similar in appearance to an x-ray "CAT" computerized axial tomography or computed tomography (CT) scan. FDG stands for [18F] (flourine 18) fluorodeoxyglucose, a radiolabeled sugar that is used to identify areas of inflammation with the PET scanner. A CT scan takes a picture of what the lungs and airways look like.
T cells are the primary cause of acute rejection of lung transplants. Because T cells must divide in order to be activated and cause rejection, imaging them while they are dividing is another way that we can determine whether acute rejection is occurring. A new PET tracer called [18F]ISO-1 (18F-labeled σ2-receptor ligand for PET, N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-18F-fluoroethoxy)-5-methylbenzamide (18F-3c), binds to dividing cells. Therefore, [18F]ISO-1 may help us measure acute rejection more accurately. [18F]ISO-1 is an investigational drug.
- Conditions
- Lung Disease
- Being tested
- [18F]FDG, [18F]ISO-1
- Keywords
- acute lung transplant rejection, neutrophilic lung inflammation, positron emission tomography imaging, [18F] fluorodeoxyglucose, [18F] ISO-1
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FDGDrug
Also called fluorodeoxyglucose
10 millicuries (mCi) of [18F]FDG will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition
[18F]ISO-1Drug
Also called F-18 labeled proliferation tracer targeting PGRMC1
8 mCi of [18F]ISO-1 will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition
| Study group | Role | What they receive |
|---|---|---|
| Grade A0 | Double-lung transplant recipients with no evidence of rejection who undergo both [18F]FDG and [18F]ISO-1 PET imaging scans Receives: Drug: [18F]FDG; Drug: [18F]ISO-1 | |
| Grades A2-3 | Double-lung transplant recipients with mild to moderate rejection who undergo both [18F]FDG and [18F]ISO-1 PET imaging scans Receives: Drug: [18F]FDG; Drug: [18F]ISO-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ki, the influx constant that describes the rate of [18F]FDG uptake, in the whole lung
Measured: This outcome measure is assessed from the [18F]FDG scan performed on Day 1.
Logan plot analysis determined distribution volume ratio (DVR) of [18F] ISO-1 uptake
Measured: This outcome measure is assessed from the [18F]ISO-1 PET scan performed on Day 2.
Secondary outcomes (1)
Progesterone receptor membrane component 1 (PGRMC1) staining of biopsy tissues and bronchoalveolar lavage cells
The biopsy specimens will be stained for proliferation markers. The bronchoalveolar lavage cells will be assessed for glucose uptake with 2-NBDG ( fluorescent glucose analog that has been used to monitor glucose uptake in live cells, as an indicator of cell viability).
Measured: Assessed after the baseline clinical bronchoscopy procedure is performed 3 days prior to FDG PET/CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startFeb 2014
- Primary completion4 Feb 2017
- Study completion4 Feb 2017
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Delphine L Chen, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02204202
- Sponsor's protocol ID
- 1R01HL121218-01-201102155
- Other IDs
- R01HL121218
- Status last verified
- Oct 2020
- First submitted
- 24 Jul 2014
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Assessment of Acute Lung Transplant Rejection
- ClinicalTrials.gov ID
- NCT02204202
- Acronym / sponsor ID
- 1R01HL121218-01-201102155
- Conditions
- Lung Disease
- Keywords
- acute lung transplant rejection, neutrophilic lung inflammation, positron emission tomography imaging, [18F] fluorodeoxyglucose, [18F] ISO-1
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2014
- Primary completion
- 4 Feb 2017 (actual)
- Study completion
- 4 Feb 2017 (actual)
- First posted
- 30 Jul 2014 (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.
The purpose of this research study is to gain understanding of the basic responses of the lungs to inflammation and specifically if there may be a better way to detect graft inflammation using non-invasive methods as well as to determine the effectiveness of immunosuppressive treatment regimens in preventing acute rejection in lung transplant recipients.
Detailed description
Positron emission tomography with fluorodeoxyglucose (FDG-PET) is a potential way we can measure lung inflammation. FDG-PET imaging is a clinically accepted and FDA-approved method that is commonly used in the diagnosis and management of cancer. PET is a machine that detects radiation and generates pictures using a donut shaped scanner similar in appearance to an x-ray "CAT" computerized axial tomography or computed tomography (CT) scan. FDG stands for [18F] (flourine 18) fluorodeoxyglucose, a radiolabeled sugar that is used to identify areas of inflammation with the PET scanner. A CT scan takes a picture of what the lungs and airways look like.
T cells are the primary cause of acute rejection of lung transplants. Because T cells must divide in order to be activated and cause rejection, imaging them while they are dividing is another way that we can determine whether acute rejection is occurring. A new PET tracer called [18F]ISO-1 (18F-labeled σ2-receptor ligand for PET, N-(4-(6,7-dimethoxy-3,-4-dihydroisoquinolin-2(1H)-yl)butyl)-2-(2-18F-fluoroethoxy)-5-methylbenzamide (18F-3c), binds to dividing cells. Therefore, [18F]ISO-1 may help us measure acute rejection more accurately. [18F]ISO-1 is an investigational drug.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grade A0 | – | Drug: [18F]FDG, Drug: [18F]ISO-1Double-lung transplant recipients with no evidence of rejection who undergo both [18F]FDG and [18F]ISO-1 PET imaging scans |
| Grades A2-3 | – | Drug: [18F]FDG, Drug: [18F]ISO-1Double-lung transplant recipients with mild to moderate rejection who undergo both [18F]FDG and [18F]ISO-1 PET imaging scans |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient within 7 months of double-lung transplantation and who is scheduled for bronchoscopy with biopsy will be eligible. Patients will be identified via the bronchoscopy schedule through the Lung Transplant Center at Barnes-Jewish Hospital / Washington University School of Medicine and approached for potential participation prior to their scheduled bronchoscopy. PET/CT imaging with [18F]FDG will be performed, if consented, no more than 3 days after results from the biopsy are reported. [18F]ISO-1 PET/CT imaging will be performed the day after [18F]FDG PET and can be performed after treatment for acute rejection has been initiated. We intend to image 30 lung transplant recipients with no evidence of rejection (grade A0) and 30 recipients with mild to moderate (grades A2-3) rejection.
Key inclusion criteria (8 listed)
- Double-lung transplant recipient
- Scheduled for bronchoscopy with transbronchial biopsy
- Capable of lying still and supine with arms raised above the head within the PET/CT scanner for ~1.25 hours
- Capable of following instructions for breathing protocol during CT portion of PET/CT
- Able and willing to give informed consent
Key exclusion criteria (6 listed)
- Glucose level > 150 mg/dl at time of [18F]FDG PET scan (however, up to 160 mg/dl, with repeat testing showing level is stable or decreasing, is acceptable)
- Pregnancy (confirmed by qualitative urine human chorionic gonadotropin (hCG) pregnancy test)
- Lactation
- Presence of implanted electronic medical device
- Enrollment in another research study of an investigational drug
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 |
|---|---|---|
| [18F]FDGAlso: fluorodeoxyglucose10 millicuries (mCi) of [18F]FDG will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition | Drug | Grade A0, Grades A2-3 |
| [18F]ISO-1Also: F-18 labeled proliferation tracer targeting PGRMC18 mCi of [18F]ISO-1 will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition | Drug | Grade A0, Grades A2-3 |
Primary outcome
Ki, the influx constant that describes the rate of [18F]FDG uptake, in the whole lung
Time frame: This outcome measure is assessed from the [18F]FDG scan performed on Day 1.
Logan plot analysis determined distribution volume ratio (DVR) of [18F] ISO-1 uptake
Time frame: This outcome measure is assessed from the [18F]ISO-1 PET scan performed on Day 2.
1 secondary outcome
Progesterone receptor membrane component 1 (PGRMC1) staining of biopsy tissues and bronchoalveolar lavage cells
Time frame: Assessed after the baseline clinical bronchoscopy procedure is performed 3 days prior to FDG PET/CT scan
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 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.
Delphine L Chen, MD principal investigator
Washington University School of Medicine
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 Lung Disease, 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 8 inclusion and 6 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 8 Oct 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: PI left institution). 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?
Ki, the influx constant that describes the rate of [18F]FDG uptake, in the whole lung (time frame: This outcome measure is assessed from the [18F]FDG scan performed on Day 1.). 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 8 Oct 2020.