Pancreatic CancerEarly Phase 1NCT00414570
An Imaging Study of [18]F-fluoro-3'-Deoxy-3'-L-fluorothymidine ([18]F-FLT) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Who Will be Treated With Gemcitabine or Other Nucleoside Analogs
A Early Phase 1 study testing [18]F-FLT PET scan in people with Pancreatic Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
The objectives of this pilot study are: (i) to compare response to chemotherapy, time to disease progression and overall survival in patients with pancreatic cancer who will be treated with gemcitabine (or other nucleoside analogs) who demonstrate [18]F-FLT uptake to those patients who do not demonstrate [18]F-FLT… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- [18]F-FLT PET scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to 6 Feb 2019
- Phase
- Early 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
- male or female ≥ 18 years of age. If female of child bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test
- patients with known locally advanced or metastatic carcinoma of the pancreas
- planned gemcitabine treatment
- calculated creatinine clearance >50ml/min (calculated by Crockcraft and Gault equation)
- able and willing to follow instructions and comply with the protocol
- provide written consent prior to participation in this study
- Karnofsky Performance Scale Score 60-100
Who cannot join
- Bilirubin ≥200 umol/L
- AST or ALT ≥5 times the upper limits of normal
- Serious medical conditions which may prevent a patient from tolerating experimental chemotherapy such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes
- uncontrolled brain metastasis. Patients who have stable brain metastasis treated with radiation or surgery who are symptomatic and a stable dose of dexamethasone are eligible
- nursing females
Trial locations and contacts
1 site in 1 country.
About this study
The objectives of this pilot study are: (i) to compare response to chemotherapy, time to disease progression and overall survival in patients with pancreatic cancer who will be treated with gemcitabine (or other nucleoside analogs) who demonstrate [18]F-FLT uptake to those patients who do not demonstrate [18]F-FLT uptake; (ii) to correlate [18]F-FLT uptake with hENT1 expression in biopsy samples where available; (iii)to determine the presence or absence of uptake, the relative uptake score (RUS), standardized uptake value (SUV), and tumor to background ratios (T/B) of [18]F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time to disease progression; and (iv) to demonstrate the safety of [18]F-FLT.
Read the detailed description
The proposed clinical trial will be an imaging, open label, non-randomized, single site pilot study in patients with locally advanced or metastatic pancreatic carcinoma who will be treated with gemcitabine or other nucleoside analogs. Study participants will receive an IV injection of 2.59 MBq/kg ± 10% of [18]F-FLT (range: 100 to 350 MBq). If clinically indicated, dynamic PET scan imaging may start immediately before the injection, followed by half-body or limited frame scanning, using either a PET/CT or PET scanner. The first [18]F-FLT PET scan for each subject will occur within 4 weeks prior to commencement of his/her treatment. Study subjects will have a follow-up [18]F-FLT-PET scan at the time of disease progression, to a maximum of two [18]F-FLT PET scans. The same imaging procedure will be followed for both [18]F-FLT PET scans. At the same time as the [18]F-FLT PET scans occur, the patients' index tumour lesions will be re-evaluated by the same imaging modality originally used to assess the index lesions. Images will be interpreted by an experienced Nuclear Medicine physician with regard to normal physiological uptake of [18]F-FLT (RUS, SUV, and T/B). The location and relative uptake of normal and abnormal [18]F-FLT biodistribution patterns will be noted and correlated with time to disease progression and hENT1 expression in biopsy samples, where available. A medical chart review will be done at regular intervals to assess response to treatment, time to disease progression, and overall survival. Disease progression will be determined using the National Cancer Institute's Response Evaluation Criteria In Solid Tumours (RECIST).
- Conditions
- Pancreatic Cancer
- Being tested
- [18]F-FLT PET scan
- Keywords
- Positron Emission Tomography (PET), 3'-deoxy-3'(18F)fluorothymidine ([18]F-FLT)
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18]F-FLT PET scanDrug
Also called [18]F-FLT Positron Emission Tomography scan
Injection of [18]F-FLT radiopharmaceutical followed by PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| [18]F-FLT PET scan | Experimental | Radioactive dose of 2.59 MBq/kg (range 100 - 350 MBq) [18]F-FLT per injection prior to Positron Emission Tomography (PET) imaging. [18]F-FLT PET scans at baseline/pre-treatment and at disease progression, up to a maximum of two separate [18]F-FLT PET scans per participant. Receives: Drug: [18]F-FLT PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare response to chemotherapy, time to disease progression and overall survival in pancreatic cancer patients treated with gemcitabine who demonstrate 18F-FLT uptake to those patients who do not demonstrate 18F-FLT uptake
Measured: 5 Years
correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available
Measured: 5 Years
Secondary outcomes (2)
determine the presence or absence of uptake, the relative uptake score (RUS) and tumor background ratios of 18F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time of disease progression
Measured: 5 Years
to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study startNov 2007
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Why it stopped: Retirement of former Qualified Investigator and lack of resources to complete study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Cross Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Michael B Sawyer, MD, Principal investigator, Cross Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414570
- Sponsor's protocol ID
- DX-FLT-001
- Status last verified
- Feb 2019
- First submitted
- 19 Dec 2006
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Imaging Study of [18]F-fluoro-3'-Deoxy-3'-L-fluorothymidine ([18]F-FLT) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Who Will be Treated With Gemcitabine or Other Nucleoside Analogs
- ClinicalTrials.gov ID
- NCT00414570
- Acronym / sponsor ID
- DX-FLT-001
- Conditions
- Pancreatic Cancer
- Keywords
- Positron Emission Tomography (PET), 3'-deoxy-3'(18F)fluorothymidine ([18]F-FLT)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Retirement of former Qualified Investigator and lack of resources to complete study
- Enrolment
- 11 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Collaborators
- Cross Cancer Institute
- Study start
- Nov 2007 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 21 Dec 2006 (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 objectives of this pilot study are: (i) to compare response to chemotherapy, time to disease progression and overall survival in patients with pancreatic cancer who will be treated with gemcitabine (or other nucleoside analogs) who demonstrate [18]F-FLT uptake to those patients who do not demonstrate [18]F-FLT uptake; (ii) to correlate [18]F-FLT uptake with hENT1 expression in biopsy samples where available; (iii)to determine the presence or absence of uptake, the relative uptake score (RUS), standardized uptake value (SUV), and tumor to background ratios (T/B) of [18]F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time to disease progression; and (iv) to demonstrate the safety of [18]F-FLT.
Detailed description
The proposed clinical trial will be an imaging, open label, non-randomized, single site pilot study in patients with locally advanced or metastatic pancreatic carcinoma who will be treated with gemcitabine or other nucleoside analogs. Study participants will receive an IV injection of 2.59 MBq/kg ± 10% of [18]F-FLT (range: 100 to 350 MBq). If clinically indicated, dynamic PET scan imaging may start immediately before the injection, followed by half-body or limited frame scanning, using either a PET/CT or PET scanner. The first [18]F-FLT PET scan for each subject will occur within 4 weeks prior to commencement of his/her treatment. Study subjects will have a follow-up [18]F-FLT-PET scan at the time of disease progression, to a maximum of two [18]F-FLT PET scans. The same imaging procedure will be followed for both [18]F-FLT PET scans. At the same time as the [18]F-FLT PET scans occur, the patients' index tumour lesions will be re-evaluated by the same imaging modality originally used to assess the index lesions. Images will be interpreted by an experienced Nuclear Medicine physician with regard to normal physiological uptake of [18]F-FLT (RUS, SUV, and T/B). The location and relative uptake of normal and abnormal [18]F-FLT biodistribution patterns will be noted and correlated with time to disease progression and hENT1 expression in biopsy samples, where available. A medical chart review will be done at regular intervals to assess response to treatment, time to disease progression, and overall survival. Disease progression will be determined using the National Cancer Institute's Response Evaluation Criteria In Solid Tumours (RECIST).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18]F-FLT PET scan | Experimental | Drug: [18]F-FLT PET scanRadioactive dose of 2.59 MBq/kg (range 100 - 350 MBq) [18]F-FLT per injection prior to Positron Emission Tomography (PET) imaging. [18]F-FLT PET scans at baseline/pre-treatment and at disease progression, up to a maximum of two separate [18]F-FLT PET scans per participant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male or female ≥ 18 years of age. If female of child bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test
- patients with known locally advanced or metastatic carcinoma of the pancreas
- planned gemcitabine treatment
- calculated creatinine clearance >50ml/min (calculated by Crockcraft and Gault equation)
- able and willing to follow instructions and comply with the protocol
Key exclusion criteria (5 listed)
- Bilirubin ≥200 umol/L
- AST or ALT ≥5 times the upper limits of normal
- Serious medical conditions which may prevent a patient from tolerating experimental chemotherapy such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections, uncontrolled diabetes
- uncontrolled brain metastasis. Patients who have stable brain metastasis treated with radiation or surgery who are symptomatic and a stable dose of dexamethasone are eligible
- nursing females
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 |
|---|---|---|
| [18]F-FLT PET scanAlso: [18]F-FLT Positron Emission Tomography scanInjection of [18]F-FLT radiopharmaceutical followed by PET imaging. | Drug | [18]F-FLT PET scan |
Primary outcome
compare response to chemotherapy, time to disease progression and overall survival in pancreatic cancer patients treated with gemcitabine who demonstrate 18F-FLT uptake to those patients who do not demonstrate 18F-FLT uptake
Time frame: 5 Years
correlate 18F-FLT uptake with hENT1 expression with biopsy samples where available
Time frame: 5 Years
2 secondary outcomes
determine the presence or absence of uptake, the relative uptake score (RUS) and tumor background ratios of 18F-FLT in patients with known carcinoma of the pancreas and assess this uptake in relation to time of disease progression
Time frame: 5 Years
to demonstrate the safety of 18F-FLT manufactured at the Edmonton PET Centre
Time frame: 5 Years
Results and safety
The study was stopped early (reason given: Retirement of former Qualified Investigator and lack of resources to complete study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
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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.
Michael B Sawyer, MD principal investigator
Cross Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [18]F-FLT PET scan in people with Pancreatic Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
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 7 inclusion and 5 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 28 Aug 2019. 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 Canada. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: Retirement of former Qualified Investigator and lack of resources to complete study). 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?
compare response to chemotherapy, time to disease progression and overall survival in pancreatic cancer patients treated with gemcitabine who demonstrate 18F-FLT uptake to those patients who do not demonstrate 18F-FLT uptake (time frame: 5 Years). 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 28 Aug 2019.