Lung CancerPhase 1SPNNCT01502670
Amino Acid Tracer (FACBC) Positron Emission Tomography for Lung Nodule
A Phase 1 study testing 18F-FACBC Radiotracer in people with Lung Cancer, run by Emory University at 1 site in United States.
Trial summary
This study will look at how the [18]FACBC goes into the lung nodules. This will hopefully lead to the development of better imaging techniques to look at lung nodules. [18]FACBC is not approved by the FDA (Food and Drug Administration). This study will help to determine if it should be approved by the FDA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 18F-FACBC Radiotracer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Jan 2013
- Phase
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be 18 years of age or older.
- Patients with a history of cancer who have a solitary pulmonary nodule between 1-3 cm in short axis with clinical and CT characteristics warranting surgical removal (see below).
- Clinical, laboratory, or diagnostic imaging findings on CT or 18F-FDG PET-CT do not suggest the possibility of the SPN being part of a metastatic process.
- Ability to lie still for PET scanning
- Patients must be able to provide written informed consent.
Who cannot join
- Age less than 18.
- Active carcinoma with known metastatic disease.
- Size of primary lesion less than 1 cm or greater than 3 cm
- Not a candidate for surgical resection or biopsy based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy.
- Inability to lie still for PET scanning
- Cannot provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of the Utility of the Novel Amino Acid Radiotracer Anti-[18 F]FACBC for the Noninvasive Imaging of Lung Nodules
This study will look at how the [18]FACBC goes into the lung nodules. This will hopefully lead to the development of better imaging techniques to look at lung nodules. [18]FACBC is not approved by the FDA (Food and Drug Administration). This study will help to determine if it should be approved by the FDA.
Read the detailed description
This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to tumor cells, as has been shown in the detection and staging of prostate cancer and for brain tumors. In this study we are going to test this new substance in patients with lung nodules. Lung nodules are a common finding. It is very important to non-invasively determine whether the nodule is cancer or not, as early cancer detection and treatment may cure the disease. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the lung nodules, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance often goes to inflammatory tissues as well. This new substance does not significantly go to inflammatory tissues, and may allow tumors in the lungs to be better identified.
- Conditions
- Lung Cancer
- Being tested
- 18F-FACBC Radiotracer
- Keywords
- Pulmonary nodules
- Medical subject headings
- Lung Neoplasms, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FACBC RadiotracerDrug
Also called Radiotracer
Test radiotracer uptake in lung nodule
| Study group | Role | What they receive |
|---|---|---|
| Lung Nodule | Experimental | Not described Receives: Drug: 18F-FACBC Radiotracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Radiotracer Uptake with Histology
We will correlate radiotracer uptake with histology results
Measured: Typically 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2012 (estimated)
- Study startMay 2009
- Primary completionJun 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Nihon Medi-Physics Co., Ltd.
- Responsible party
- Principal investigator, David M. Schuster, MD, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502670
- Sponsor's protocol ID
- IRB00006621
- Other IDs
- 14701
- Acronym
- SPN
- Status last verified
- Nov 2013
- First submitted
- 21 Dec 2011
- Last updated
- 19 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amzat R, Taleghani P, Miller DL, Beitler JJ, Bellamy LM, Nye JA, Yu W, Savir-Baruch B, Osunkoya AO, Chen Z, Auffermann WF, Goodman MM, Schuster DM. Pilot study of the utility of the synthetic PET amino-acid radiotracer anti-1-amino-3-[(18)F]fluorocyclobutane-1-carboxylic acid for the noninvasive imaging of pulmonary lesions. Mol Imaging Biol. 2013 Oct;15(5):633-43. doi: 10.1007/s11307-012-0606-7.
PubMed 23595643
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Utility of the Novel Amino Acid Radiotracer Anti-[18 F]FACBC for the Noninvasive Imaging of Lung Nodules
- ClinicalTrials.gov ID
- NCT01502670
- Acronym / sponsor ID
- SPN / IRB00006621
- Conditions
- Lung Cancer
- Keywords
- Pulmonary nodules
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Nihon Medi-Physics Co., Ltd.
- Study start
- May 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 2 Jan 2012 (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 study will look at how the [18]FACBC goes into the lung nodules. This will hopefully lead to the development of better imaging techniques to look at lung nodules. [18]FACBC is not approved by the FDA (Food and Drug Administration). This study will help to determine if it should be approved by the FDA.
Detailed description
This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to tumor cells, as has been shown in the detection and staging of prostate cancer and for brain tumors. In this study we are going to test this new substance in patients with lung nodules. Lung nodules are a common finding. It is very important to non-invasively determine whether the nodule is cancer or not, as early cancer detection and treatment may cure the disease. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the lung nodules, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance often goes to inflammatory tissues as well. This new substance does not significantly go to inflammatory tissues, and may allow tumors in the lungs to be better identified.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Nodule | Experimental | Drug: 18F-FACBC Radiotracer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients must be 18 years of age or older.
- Patients with a history of cancer who have a solitary pulmonary nodule between 1-3 cm in short axis with clinical and CT characteristics warranting surgical removal (see below).
- Clinical, laboratory, or diagnostic imaging findings on CT or 18F-FDG PET-CT do not suggest the possibility of the SPN being part of a metastatic process.
- Ability to lie still for PET scanning
- Patients must be able to provide written informed consent.
Key exclusion criteria (6 listed)
- Age less than 18.
- Active carcinoma with known metastatic disease.
- Size of primary lesion less than 1 cm or greater than 3 cm
- Not a candidate for surgical resection or biopsy based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy.
- Inability to lie still for PET scanning
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-FACBC RadiotracerAlso: RadiotracerTest radiotracer uptake in lung nodule | Drug | Lung Nodule |
Primary outcome
Correlation of Radiotracer Uptake with Histology
Time frame: Typically 1-2 months
We will correlate radiotracer uptake with histology results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2013.
- Results publication: PubMed 23595643Amzat R, Taleghani P, Miller DL, Beitler JJ, Bellamy LM, Nye JA, Yu W, Savir-Baruch B, Osunkoya AO, Chen Z, Auffermann WF, Goodman MM, Schuster DM. Pilot study of the utility of the synthetic PET amino-acid radiotracer anti-1-amino-3-[(18)F]fluorocyclobutane-1-carboxylic acid for the noninvasive imaging of pulmonary lesions. Mol Imaging Biol. 2013 Oct;15(5):633-43. doi: 10.1007/s11307-012-0606-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-FACBC Radiotracer in people with Lung Cancer, run by Emory University 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 5 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: finished, as of the sponsor's last update on 19 Nov 2013. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation of Radiotracer Uptake with Histology (time frame: Typically 1-2 months). 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 NCT01502670, which also lists 1 linked publication.
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 19 Nov 2013.