Squamous Cell CarcinomaEarly Phase 1NCT01755650
Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies
A Early Phase 1 study testing 18F FPM in people with Squamous Cell Carcinoma, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial summary
The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma
- What is being tested?
- 18F FPM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2011to 3 Nov 2017
- 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
- Written informed consent obtained prior to any protocol-specific procedures
- Male and female patients with histologically confirmed squamous cell carcinoma
- At least one site of active malignancy, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
- Age >/= 18 years
- Life expectancy >/= 3 months
- ECOG Performance score of 0-2
Who cannot join
- Pregnant or breastfeeding females
- Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F FPM PET/CT scan
- Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
- Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.
The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.
- Conditions
- Squamous Cell Carcinoma
- Being tested
- 18F FPM
- Keywords
- 18F FPM, PET/CT, microdosing
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F FPMRadiation
| Study group | Role | What they receive |
|---|---|---|
| D-18F FPM | Experimental | Not described Receives: Radiation: 18F FPM |
| L-18F FPM | Experimental | Not described Receives: Radiation: 18F FPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration
Measured: Up to 28 days following 18F FPM administration (+/- 7 days)
Secondary outcomes (3)
Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.
Measured: 10, 30, 60 and 120 minutes post 18F FPM administration
Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.
Measured: 30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
Absorbed organ doses expressed as micro Sv/MBq of administered D-18F FPM and L-18F FPM, and whole body dose expressed as milliSv/200MBq of administered dose
Measured: 10, 30, 60 and 120 minutes post 18F FPM administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startOct 2011
- Primary completion3 Nov 2017
- Study completion3 Nov 2017
Why it stopped: 6 patients were recuited. Due to inability of the tracer to detect regions of interest sufficiently, the trial was closed early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ben Solomon, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755650
- Sponsor's protocol ID
- 11/31
- Status last verified
- Sep 2023
- First submitted
- 16 Dec 2012
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.
- ClinicalTrials.gov ID
- NCT01755650
- Acronym / sponsor ID
- 11/31
- Conditions
- Squamous Cell Carcinoma
- Keywords
- 18F FPM, PET/CT, microdosing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 6 patients were recuited. Due to inability of the tracer to detect regions of interest sufficiently, the trial was closed early.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 24 Dec 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.
The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-18F FPM | Experimental | Radiation: 18F FPM |
| L-18F FPM | Experimental | Radiation: 18F FPM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained prior to any protocol-specific procedures
- Male and female patients with histologically confirmed squamous cell carcinoma
- At least one site of active malignancy, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care
- Age >/= 18 years
- Life expectancy >/= 3 months
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding females
- Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F FPM PET/CT scan
- Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study
- Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent
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 FPM | Radiation | D-18F FPM, L-18F FPM |
Primary outcome
Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration
Time frame: Up to 28 days following 18F FPM administration (+/- 7 days)
3 secondary outcomes
Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.
Time frame: 10, 30, 60 and 120 minutes post 18F FPM administration
Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.
Time frame: 30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration
Absorbed organ doses expressed as micro Sv/MBq of administered D-18F FPM and L-18F FPM, and whole body dose expressed as milliSv/200MBq of administered dose
Time frame: 10, 30, 60 and 120 minutes post 18F FPM administration
Results and safety
The study was stopped early (reason given: 6 patients were recuited. Due to inability of the tracer to detect regions of interest sufficiently, the trial was closed early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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.
Ben Solomon principal investigator
Peter MacCallum Cancer Centre, Australia
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 18F FPM in people with Squamous Cell Carcinoma, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
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 6 inclusion and 4 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 13 Sep 2023. 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 Australia. 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: 6 patients were recuited. Due to inability of the tracer to detect regions of interest sufficiently, the trial was closed early.). 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?
Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration (time frame: Up to 28 days following 18F FPM administration (+/- 7 days)). 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 13 Sep 2023.