Lung CancerFLT101NCT00847509
A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation
A study testing [F-18]FLT in people with Lung Cancer and Head and Neck Cancer, run by Siemens Molecular Imaging at 2 sites in United States.
Trial summary
Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Head and Neck Cancer
- What is being tested?
- [F-18]FLT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient provides written Informed Consent and is willing to comply with protocol requirements
- Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
- Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
- Patient has a diagnosis of one of the following malignancies using the TNM Staging System:
- Lung cancer (T3 grade up, node positive, but no metastatic disease)
- Head and neck cancer (T3 grade up, node positive, but no metastatic disease)
Show all 12Show fewer
- Patient has undergone a comparative, diagnostic procedure with lesion(s) visible, other than ultrasound, that includes, but is not limited to computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine imaging, endoscopy, laparoscopy, standard abdominal x-ray, biopsy and/or surgery for one of the above mentioned areas
- Patient is scheduled to start radiotherapy or a chemoradiotherapy regimen for curative intent
- As a part of his/her standard radiotherapy or chemoradiotherapy regimen, patient is scheduled to have clinical [F-18]FDG PET scans pre treatment and post treatment (at about 4 weeks (±1 week) after the start of therapy)
- Patient is scheduled to have the investigational, pre treatment [F-18] FLT PET scan recommended to be within ± 2 days of the clinical, pre treatment [F-18] FDG PET scan
- Patient has not received or intends to receive 5-fluorouracil (chemotherapeutic agent)
- Patient has a score of greater than or equal to (>/=) 60% on the Karnofsky Performance Status Scale
Who cannot join
- Patient is a pregnant or lactating female. Exclude the possibility of pregnancy:
- by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration
- by surgical history (eg, tubal ligation or hysterectomy)
- by patient's history of being post menopausal with a minimum 1 year without menses
- Patient is undergoing treatment with palliative intent
- Patient has received an investigational compound and/or medical device within 14 days before admission into this study
- Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations
- Patient is determined by the Investigator that he/she is clinically unsuitable for the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Excel Diagnostics Imaging Clinics
Houston, Texas, 77042
Hoag Memorial Hospital
Newport Beach, California, 92658
About this study
Official title: A Phase II/III, Open Label, Non-Randomized, Multi - Center Study Of Positron Emission Tomography (PET) Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.
Read the detailed description
PHASE: II/III
OBJECTIVES:
Primary: To investigate the clinical value of serial quantitative [F-18] FLT positron image assessment of tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial quantitative [F-18] FDG images
Secondary: To gain additional clinical information and experience with [F-18]FLT to guide the design of a future, pivotal, Phase III trial where changes in tumor proliferation from pre-treatment baseline values can be used as a early indicator of response to therapy regimens.
DESIGN: Open label, nonrandomized, uncontrolled, single group assignment
DURATION: Pre treatment [F-18] FLT PET scan following a clinical [F-18] FDG PET scan followed by post treatment [F-18] FLT PET scan and a post treatment, clinical [F-18] FDG PET scan at 4 weeks (±1 week) to monitor radiotherapy or chemoradiotherapy.
PROCEDURES: Informed consent, collection of demographic information, medical history, physical examinations, vital signs, 12-lead ECGs, concomitant medication collection, monitor adverse events, pre treatment [F-18] FLT PET scan and post treatment [F-18] FLT PET scan
SUBJECTS: Approximately 60 patients will be enrolled with confirmed lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil) to be eligible. This allows for approximately 40 evaluable patients to complete this study at approximately four to eight sites and conducted in the United States.
- Conditions
- Lung Cancer, Head and Neck Cancer
- Being tested
- [F-18]FLT
- Keywords
- lung cancer, head and neck cancer, radiotherapy, chemoradiotherapy, radiation, chemoradiation, FLT, [F-18]FLT, FDG, [F-18]FDG
- Medical subject headings
- Lung Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]FLTDrug
Also called [F-18] FLT, FLT
The individual doses of [F-18]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| FLT PET scan | Experimental | Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator. Receives: Drug: [F-18]FLT |
What is being measured
The primary outcome is the main question the study is designed to answer.
[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan
The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.
Measured: 3-5 weeks after the start of radiation or chemo radio therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Siemens Molecular Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ebrahim S Delpassand, MD, Principal investigator, Excel Diagnostics Imaging ClinicsMichael Brandt-Zawadzki, MD, Principal investigator, Hoag Memorial Hospital, Newport Beach, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847509
- Sponsor's protocol ID
- FLT101
- Acronym
- FLT101
- Status last verified
- Jul 2013
- First submitted
- 17 Feb 2009
- Last updated
- 27 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III, Open Label, Non-Randomized, Multi - Center Study Of Positron Emission Tomography (PET) Imaging With [F-18] FLT Compared to [F-18] FDG in Cancer Patients for Treatment Evaluation
- ClinicalTrials.gov ID
- NCT00847509
- Acronym / sponsor ID
- FLT101 / FLT101
- Conditions
- Lung Cancer, Head and Neck Cancer
- Keywords
- lung cancer, head and neck cancer, radiotherapy, chemoradiotherapy, radiation, chemoradiation, FLT, [F-18]FLT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Siemens Molecular ImagingIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 27 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks after the start of therapy) post PET/CT imaging visit. This study will evaluate the FLT and FDG images for tumor proliferation rates for early assessment of tumor response to radiation or chemo-radiation combo.
Detailed description
PHASE: II/III
OBJECTIVES:
Primary: To investigate the clinical value of serial quantitative [F-18] FLT positron image assessment of tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial quantitative [F-18] FDG images
Secondary: To gain additional clinical information and experience with [F-18]FLT to guide the design of a future, pivotal, Phase III trial where changes in tumor proliferation from pre-treatment baseline values can be used as a early indicator of response to therapy regimens.
DESIGN: Open label, nonrandomized, uncontrolled, single group assignment
DURATION: Pre treatment [F-18] FLT PET scan following a clinical [F-18] FDG PET scan followed by post treatment [F-18] FLT PET scan and a post treatment, clinical [F-18] FDG PET scan at 4 weeks (±1 week) to monitor radiotherapy or chemoradiotherapy.
PROCEDURES: Informed consent, collection of demographic information, medical history, physical examinations, vital signs, 12-lead ECGs, concomitant medication collection, monitor adverse events, pre treatment [F-18] FLT PET scan and post treatment [F-18] FLT PET scan
SUBJECTS: Approximately 60 patients will be enrolled with confirmed lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil) to be eligible. This allows for approximately 40 evaluable patients to complete this study at approximately four to eight sites and conducted in the United States.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FLT PET scan | Experimental | Drug: [F-18]FLTOpen label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient provides written Informed Consent and is willing to comply with protocol requirements
- Patient is at least 18 years of age on the day of dosing (male or female of any race or ethnicity)
- Patient is capable of lying still in the PET scanner for the protocol required time frame(s)
- Patient has a diagnosis of one of the following malignancies using the TNM Staging System:
- Lung cancer (T3 grade up, node positive, but no metastatic disease)
Key exclusion criteria (8 listed)
- Patient is a pregnant or lactating female. Exclude the possibility of pregnancy:
- by testing on site at the institution (serum or urine βHCG) within 48 hours prior to the start of each investigational product administration
- by surgical history (eg, tubal ligation or hysterectomy)
- by patient's history of being post menopausal with a minimum 1 year without menses
- Patient is undergoing treatment with palliative intent
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 |
|---|---|---|
| [F-18]FLTAlso: [F-18] FLT, FLTThe individual doses of [F-18]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging. | Drug | FLT PET scan |
Primary outcome
[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan
Time frame: 3-5 weeks after the start of radiation or chemo radio therapy
The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ebrahim S Delpassand, MD principal investigator
Excel Diagnostics Imaging Clinics
Michael Brandt-Zawadzki, MD principal investigator
Hoag Memorial Hospital, Newport Beach, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [F-18]FLT in people with Lung Cancer and Head and Neck Cancer, run by Siemens Molecular Imaging at 2 sites 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 12 inclusion and 8 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 27 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 27 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
[F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan (time frame: 3-5 weeks after the start of radiation or chemo radio therapy). 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 27 Sep 2013.