Breast CancerPhase 1FISO PET/CTNCT00968656
Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1
A Phase 1 study testing PET/CT, Laboratory Testing and Safety Testing in people with Breast Cancer and Head and Neck Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The main purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive tracer called 18F-ISO-1 can accurately identify how quickly cancer cells are growing or dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Head and Neck Cancer, Diffuse Large B-cell Lymphoma
- What is being tested?
- PET/CT, Laboratory Testing and Safety Testing
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2011
- 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 18 years of age or older with biopsy-proven breast cancer, head \& neck cancer or diffuse large B-cell lymphoma.
- For determination of Ki-67, S-phase, mitotic index, and sigma-2 receptor assessment, cancer subjects must be scheduled to undergo surgical resection of the primary tumor without intervening therapy, or be scheduled to undergo (or have already undergone) tissue sampling as either standard of care or part of another research project prior to any planned treatment for their cancer. For tumor sigma-2 receptors assessment, about 0.5 g of fresh tumor tissue kept frozen on dry ice is needed, other proliferative markers may be determined on a much smaller specimen. Thus, it is possible that the analysis of sigma-2 receptors may not be possible in all patients, as obtaining 0.5 g tumor specimen may not practical in all patients.
- Newly diagnosed breast cancer, head \& neck cancer, or diffuse large B-cell lymphoma subjects should have a primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination and who have not received any treatment for their cancer.
- Able to give informed consent.
- Not currently pregnant or nursing: Female subjects must be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or post menopausal (cessation of menses for more than 1 year). If of childbearing potential, a urine pregnancy test must be performed within the 24 hour period immediately prior to administration of [18F]ISO-1 and determined to be negative.
Who cannot join
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years. Lymphoma patients who have received treatment in the past but have a new diagnosis of diffuse large B-cell lymphoma are eligible to participate providing they will undergo tissue sampling as specified in the inclusion criteria.
- Unable to tolerate 60-90 minutes of PET imaging.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University / Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
The main purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive tracer called 18F-ISO-1 can accurately identify how quickly cancer cells are growing or dividing. A second purpose for this study is to determine, by taking pictures, what tissues and organs of the body take up 18F-ISO-1 naturally and to determine how that uptake changes over time.
- Being tested
- PET/CT, Laboratory Testing, Safety Testing, Immunohistochemistry staining, F-18-ISO
- Keywords
- Breast cancer, Head and Neck Cancer, Diffuse Large B-cell lymphoma, Cellular proliferation
- Medical subject headings
- Breast Neoplasms, Head and Neck Neoplasms, Lymphoma, Large B-Cell, Diffuse, Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CTRadiation
Patients receive F-18-ISO-1 i.v. and undergo PET/CT imaging at 2-3 time points following the injection.
Laboratory TestingOther
Blood and urine samples for laboratory analysis and radioactive counts will be obtained during the imaging sessions
Safety TestingOther
ECG tracings, and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during, and after the imaging sessions.
Immunohistochemistry stainingOther
If available tissue from a biopsy or surgery will be tested cellular proliferation markers such as Ki67 and sigma 2 receptors
F-18-ISODrug
Patients receive F-18-ISO-1 i.v.
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary out come is to assess the diagnostic quality of [18F]ISO-1-PET/CT images at the proposed 8 mCi dose.
Measured: 3 years
Secondary outcomes (1)
Secondary outcome is to quantitatively determine the relationship between tumor [18F]ISO-1 uptake and Ki-67, S-phase, mitotic index and sigma-2 receptors content of the tumor.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Isotrace Technologies
- Responsible party
- Principal investigator, Farrokh Dehdashti, Washington University School of Medicine
- Investigators
- Farrokh Dehdashti, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968656
- Sponsor's protocol ID
- FISO 08-1010
- Acronym
- FISO PET/CT
- Status last verified
- Dec 2014
- First submitted
- 28 Aug 2009
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1
- ClinicalTrials.gov ID
- NCT00968656
- Acronym / sponsor ID
- FISO PET/CT / FISO 08-1010
- Keywords
- Breast cancer, Head and Neck Cancer, Diffuse Large B-cell lymphoma, Cellular proliferation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Isotrace Technologies
- Study start
- Jan 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 31 Aug 2009 (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 main purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive tracer called 18F-ISO-1 can accurately identify how quickly cancer cells are growing or dividing. A second purpose for this study is to determine, by taking pictures, what tissues and organs of the body take up 18F-ISO-1 naturally and to determine how that uptake changes over time.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 18 years of age or older with biopsy-proven breast cancer, head \& neck cancer or diffuse large B-cell lymphoma.
- For determination of Ki-67, S-phase, mitotic index, and sigma-2 receptor assessment, cancer subjects must be scheduled to undergo surgical resection of the primary tumor without intervening therapy, or be scheduled to undergo (or have already undergone) tissue sampling as either standard of care or part of another research project prior to any planned treatment for their cancer. For tumor sigma-2 receptors assessment, about 0.5 g of fresh tumor tissue kept frozen on dry ice is needed, other proliferative markers may be determined on a much smaller specimen. Thus, it is possible that the analysis of sigma-2 receptors may not be possible in all patients, as obtaining 0.5 g tumor specimen may not practical in all patients.
- Newly diagnosed breast cancer, head \& neck cancer, or diffuse large B-cell lymphoma subjects should have a primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination and who have not received any treatment for their cancer.
- Able to give informed consent.
- Not currently pregnant or nursing: Female subjects must be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or post menopausal (cessation of menses for more than 1 year). If of childbearing potential, a urine pregnancy test must be performed within the 24 hour period immediately prior to administration of [18F]ISO-1 and determined to be negative.
Key exclusion criteria (2 listed)
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years. Lymphoma patients who have received treatment in the past but have a new diagnosis of diffuse large B-cell lymphoma are eligible to participate providing they will undergo tissue sampling as specified in the inclusion criteria.
- Unable to tolerate 60-90 minutes of PET imaging.
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 |
|---|---|---|
| PET/CTPatients receive F-18-ISO-1 i.v. and undergo PET/CT imaging at 2-3 time points following the injection. | Radiation | – |
| Laboratory TestingBlood and urine samples for laboratory analysis and radioactive counts will be obtained during the imaging sessions | Other | – |
| Safety TestingECG tracings, and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during, and after the imaging sessions. | Other | – |
| Immunohistochemistry stainingIf available tissue from a biopsy or surgery will be tested cellular proliferation markers such as Ki67 and sigma 2 receptors | Other | – |
| F-18-ISOPatients receive F-18-ISO-1 i.v. | Drug | – |
Primary outcome
The primary out come is to assess the diagnostic quality of [18F]ISO-1-PET/CT images at the proposed 8 mCi dose.
Time frame: 3 years
1 secondary outcome
Secondary outcome is to quantitatively determine the relationship between tumor [18F]ISO-1 uptake and Ki-67, S-phase, mitotic index and sigma-2 receptors content of the tumor.
Time frame: 3 years
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 9 Dec 2014.
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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.
Farrokh Dehdashti, M.D. 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?
A Phase 1 study testing PET/CT, Laboratory Testing and Safety Testing in people with Breast Cancer and Head and Neck Cancer, 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 5 inclusion and 2 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 9 Dec 2014. 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?
The primary out come is to assess the diagnostic quality of [18F]ISO-1-PET/CT images at the proposed 8 mCi dose. (time frame: 3 years). 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 9 Dec 2014.