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MelanomaPhase 1NCT02891616

18F-FLT PET Imaging in Patients With Advanced Melanoma

A Phase 1 study testing fludeoxyglucose F 18, Positron emission tomography-computed tomography and 18F-fluorothymidine in people with Melanoma, run by Washington University School of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

In the current study, advanced positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to validate our hypothesis that melanoma patients receiving Dual-Immune Checkpoint Blockade (DICB) therapy, who ultimately achieve clinical… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
fludeoxyglucose F 18, Positron emission tomography-computed tomography and 18F-fluorothymidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
10 Oct 2016to 31 Dec 2017
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 have histologically or cytologically confirmed diagnosis of unresectable, stage III or metastatic melanoma.
  • Patients who are eligible to receive combined dual immune-checkpoint blockade therapy with ipilimumab and nivolumab, per referring oncologist.
  • Life expectancy ≥ 6 months.
  • Disease that is measurable. This is defined as lesions measuring at least 10mm on radiologic imaging.
  • The Eastern Cooperative Oncology Group (ECOG) performance status of 1 or better
  • Age ≥18 years.
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  • Normal organ and marrow function as defined below
  • Aspartate aminotransferase (AST) (SGOT) or alanine aminotransferase (ALT) (SGPT) ≤2.5 × institutional upper limit of normal (≤5 x upper limit of normal for patient with liver metastasis)
  • Total bilirubin within 1.5 x institutional level of normal or direct bilirubin ≤ upper limit of normal (ULN) for patient with total bilirubin levels > 1.5 ULN)
  • Hemoglobin ≥ 9.0g/dL or ≥5.6mmol/L
  • Absolute neutrophil count ≥1000/mcL
  • Platelets ≥ 75K/mcL
  • Women of child-bearing potential must have a negative urinary or serum pregnancy test within 7 days of baseline imaging.

Who cannot join

  • Patient may not be receiving any other investigational agents
  • Significant auto-immune disease requiring hospitalization within the past two years or any history of life-threatening auto-immune disease
  • Immunosuppressive therapy including systemic corticosteroids except for maintenance dosing for adrenal insufficiency
  • Known additional malignancy that is progressing or requires active treatment with the exceptions of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Active autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents with the exceptions of replacement dose steroids for adrenal insufficiency, vitiligo, resolved childhood asthma/atopy, intermittent use of inhaled steroids, local steroid injections, hypothyroidism stable on hormone replacement, and Sjogren's syndrome
  • Active tuberculosis
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  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, autoimmune diseases, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients with a pacemaker, stainless steel aneurysm clip or any other magnetic resonance (MR) contraindicated implant or foreign body would warrant exclusion from this study. Pacemakers may be reprogrammed or turned off by the strong MRI magnetic field. Radio-frequency (RF) fields in MR can also cause severe heating of pacemaker lead tips. Steel aneurysm clips are prone to torque in the strong MR field which can displace the clips and may damage the vessel, resulting in hemorrhage, and/or death.
  • History of pneumonitis requiring hospitalization or systemic immune suppressive therapy.
  • Pregnant women are excluded from this study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Early Assessment of Response to Dual Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma Using 18F-FLT PET/CT and PET/MR

In the current study, advanced positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance (PET/MR) imaging methods will be used to validate our hypothesis that melanoma patients receiving Dual-Immune Checkpoint Blockade (DICB) therapy, who ultimately achieve clinical benefit, will have an increase, or "FLARE", in tumor FLT and/or FDG uptake from baseline, as seen after cycle#1 of treatment, and that after 2 cycles of treatment responders will have a decline in FLT and FDG uptake, in comparison to the patients classified as "non-responders". In addition, alterations in tumor apparent diffusion coefficient (ADC) on diffusion-weighted magnetic resonance imaging (DW/MRI) will be evaluated, expecting after cycle#1: transient reductions in ADC due to lymphocyte proliferation, increased cellularity and restriction of water movement in responding patients, with these patients tumors having increased ADC at 2 cycles into therapy associated with tumor necrosis. This study will evaluate rather early PET imaging with FLT and FDG is a useful imaging biomarker of response to DICB.

Conditions
Melanoma
Being tested
fludeoxyglucose F 18, Positron emission tomography-computed tomography, 18F-fluorothymidine, Positron emission tomography-magnetic resonance imaging
Keywords
Melanoma, 18F-FLT, 18F-FDG, PET/CT, PET/MR
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fludeoxyglucose F 18Drug

    Also called Fludeoxyglucose (18F), FDG

  • Positron emission tomography-computed tomographyDevice

    Also called PET/CT

  • 18F-fluorothymidineDrug

    Also called FLT

  • Positron emission tomography-magnetic resonance imagingDevice

    Also called PET/MRI, PET/MR

Study groups in NCT02891616
Study groupRoleWhat they receive
FDG-PET/CT + FLT-PET/CT + PET/MRExperimental-Baseline, Week 3 (between days 14-20), Week 6 (between days 35-41) * FDG-PET/CT - Patients required to fast for at least 4 hours prior to FDG administration. Roughly 60 minutes prior to PET/CT imaging, FDG will be administered via IV bolus injection. A CT will be performed immediately before PET imaging. Whole body PET imaging will be performed for a total of about 30 minutes. * FLT-PET/CT - Patients required to fast for at least 4 hours prior to FLT administration. Roughly 80 minutes prior to PET/CT imaging, FLT will be administered via IV bolus injection. A CT will be performed immediately before PET imaging. Whole body PET imaging will be performed for a total of about 30 minutes. * PET/MR - A limited whole body scan performed immediately following PET/CT imaging when possible. Should be performed at least once at each time-point. This scan will be of a more limited area and be performed for no more than 30 minutes.
Receives: Drug: fludeoxyglucose F 18; Device: Positron emission tomography-computed tomography; Drug: 18F-fluorothymidine; Device: Positron emission tomography-magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean difference in FLT uptake between responders and non-responders

    Measured: Baseline and Week 3

  2. Mean difference in FLT uptake between responders and non-responders

    Measured: Baseline and Week 6

Secondary outcomes (4)

  1. Mean difference in FDG uptake between responders and non-responders

    Measured: Baseline and Week 3

  2. Mean difference in FDG uptake between responders and non-responders

    Measured: Baseline and Week 6

  3. Change in ADC on DW-MRI

    Measured: Baseline and Week 3

  4. Change in ADC on DW-MRI

    Measured: Baseline and Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2016 (estimated)
  2. Study start10 Oct 2016
  3. Primary completion31 Dec 2017
  4. Study completion31 Dec 2017

Why it stopped: Low accrual rate

Resources

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
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02891616
Sponsor's protocol ID
201602062
Status last verified
Jul 2019
First submitted
31 Aug 2016
Last updated
17 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing fludeoxyglucose F 18, Positron emission tomography-computed tomography and 18F-fluorothymidine in people with Melanoma, 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 13 inclusion and 10 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 17 Jul 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 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 was stopped early (reason given: Low accrual rate). 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?

Mean difference in FLT uptake between responders and non-responders (time frame: Baseline and Week 3). 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?

On the ClinicalTrials.gov record for NCT02891616.

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 17 Jul 2019.

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