Pancreatic AdenocarcinomaPACMINCT03202199
Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma.
A study testing PET/MRI in people with Pancreatic Adenocarcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of this study was to assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- What is being tested?
- PET/MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2017to 1 Jul 2021
- Phase
- Interventional
- 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
- Age > 18yo
- Locally advanced or borderline resectable pancreatic adenocarcinoma, according to the NCCN classification
- Eligible for neoadjuvant chemotherapy ± radiation therapy, according to the local tumor board
- With contraception if fertile woman
- With informed consent obtained
- Affiliated to French health care system
Who cannot join
- Previous treatment for the pancreatic adenocarcinoma
- Metastases
- Contra-indication to MRI acquisition (pace maker, metallic device, ..)
- Contra-indication to PET acquisition (non controlled diabetes with glycaemia > 11 mmol/L)
- Pregnancy or breast feeding
- Patient unable to give his consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Pitié Salpetriere Hospital
Paris
Mathilde WAGNER, MD, PhD, 0033142178305, mathilde.wagner@aphp.fr
About this study
Official title: Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. PACMI (Pancreatic AdenoCarcinoma Multimodality Imaging)
The aim of this study was to assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Read the detailed description
Background: Pancreatic cancer is the 8th more common cancer in the world. At diagnosis, majority of patients present with unresectable locally advanced disease. Standard of care therapy for locally advanced pancreatic cancer includes chemotherapy ± radiation therapy. It is published that computed tomography underestimate the effectiveness of neoajuvant treatment and there is a lack of criteria allowing identifying the responders. The misinterpretation of scans may be linked to the large desmoplatic reaction, present in pancreatic cancer, which would not be expected to regress. PET-MR is an imaging technique that associates PET and MR imaging, performed during the same examination. The main hypothesis is that PET-MR imaging could accurately identify resectable and no resectable pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Primary aim Assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy
Secondary aims Assess the accuracy of quantitative PET-MRI parameters to predict resectability and response of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy Compare accuracy of PET-MRI and CT to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Assess inter and intra observer reproducibility of PET-MRI reading CT to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Number of subjects 125 Number of centers 8
Design 2 PET-MRI examination will be performed, one before the beginning of the neoadjuvant/induction treatment, and the second one after the neoadjuvant/induction treatment and less than 30 days before the surgery. The PET-MRI examinations will include whole body and organ specific imaging.
The whole body workflow will include
- [18F]-2-fluoro-2-deoxy-D-glucose PET acquisition
- T1-mDIXON imaging (for attenuation correction calculation)
- diffusion-weighted imaging
- T1-DIXON imaging post gadolinium chelate injection. The organ specific workflow will be focused on the abdominal area, including the liver and the pancreas, and will include
- [18F]-2-fluoro-2-deoxy-D-glucose PET acquisition,
- T2-weighted imaging with and without fat saturation,
- T1-DIXON imaging before and after dynamic injection of gadolinium chelate,
- diffusion-weighted imaging,
- IVIM-diffusion weighted imaging acquisition covering the pancreatic lesion. Qualitative analysis of PET-MRI using a Likert score will be compared to pathological results in order to obtain the accuracy of PET-MRI for resectability assessement.
- Conditions
- Pancreatic Adenocarcinoma
- Being tested
- PET/MRI
- Keywords
- Adenocarcinoma, pancreas, PET/MRI
- Medical subject headings
- Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRIDevice
2 PET/MRI examinations
| Study group | Role | What they receive |
|---|---|---|
| PET/MRI | Experimental | PET/MRI examination Receives: Device: PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment
Measured: PET/MRI performed less than one month before the surgery
Secondary outcomes (3)
Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for resectability
Measured: PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery
Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for response evaluation
Measured: PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery
Comparison of the accuracies of PT MRI and CT for resectability assessment
Measured: CT and PET MRI performed less than one month before the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start19 Jun 2017
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde WAGNER, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202199
- Sponsor's protocol ID
- P150930
- Acronym
- PACMI
- Status last verified
- Jun 2017
- First submitted
- 27 Jun 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Response Assessment by Combined PET-MRI in Borderline and Locally Advanced Pancreatic Adenocarcinoma. PACMI (Pancreatic AdenoCarcinoma Multimodality Imaging)
- ClinicalTrials.gov ID
- NCT03202199
- Acronym / sponsor ID
- PACMI / P150930
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Adenocarcinoma, pancreas, PET/MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 28 Jun 2017 (actual)
- 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 aim of this study was to assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Detailed description
Background: Pancreatic cancer is the 8th more common cancer in the world. At diagnosis, majority of patients present with unresectable locally advanced disease. Standard of care therapy for locally advanced pancreatic cancer includes chemotherapy ± radiation therapy. It is published that computed tomography underestimate the effectiveness of neoajuvant treatment and there is a lack of criteria allowing identifying the responders. The misinterpretation of scans may be linked to the large desmoplatic reaction, present in pancreatic cancer, which would not be expected to regress. PET-MR is an imaging technique that associates PET and MR imaging, performed during the same examination. The main hypothesis is that PET-MR imaging could accurately identify resectable and no resectable pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Primary aim Assess the diagnostic accuracy of PET-MRI to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy
Secondary aims Assess the accuracy of quantitative PET-MRI parameters to predict resectability and response of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy Compare accuracy of PET-MRI and CT to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Assess inter and intra observer reproducibility of PET-MRI reading CT to predict resectability of pancreatic adenocarcinoma after neoadjuvant chemotherapy ± radiation therapy.
Number of subjects 125 Number of centers 8
Design 2 PET-MRI examination will be performed, one before the beginning of the neoadjuvant/induction treatment, and the second one after the neoadjuvant/induction treatment and less than 30 days before the surgery. The PET-MRI examinations will include whole body and organ specific imaging.
The whole body workflow will include
- [18F]-2-fluoro-2-deoxy-D-glucose PET acquisition
- T1-mDIXON imaging (for attenuation correction calculation)
- diffusion-weighted imaging
- T1-DIXON imaging post gadolinium chelate injection. The organ specific workflow will be focused on the abdominal area, including the liver and the pancreas, and will include
- [18F]-2-fluoro-2-deoxy-D-glucose PET acquisition,
- T2-weighted imaging with and without fat saturation,
- T1-DIXON imaging before and after dynamic injection of gadolinium chelate,
- diffusion-weighted imaging,
- IVIM-diffusion weighted imaging acquisition covering the pancreatic lesion. Qualitative analysis of PET-MRI using a Likert score will be compared to pathological results in order to obtain the accuracy of PET-MRI for resectability assessement.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MRI | Experimental | Device: PET/MRIPET/MRI examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18yo
- Locally advanced or borderline resectable pancreatic adenocarcinoma, according to the NCCN classification
- Eligible for neoadjuvant chemotherapy ± radiation therapy, according to the local tumor board
- With contraception if fertile woman
- With informed consent obtained
Key exclusion criteria (6 listed)
- Previous treatment for the pancreatic adenocarcinoma
- Metastases
- Contra-indication to MRI acquisition (pace maker, metallic device, ..)
- Contra-indication to PET acquisition (non controlled diabetes with glycaemia > 11 mmol/L)
- Pregnancy or breast feeding
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/MRI2 PET/MRI examinations | Device | PET/MRI |
Primary outcome
Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment
Time frame: PET/MRI performed less than one month before the surgery
3 secondary outcomes
Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for resectability
Time frame: PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery
Accuracy of tumor size, ADC, D, D*, F and SUVmax at baseline, before surgery and their variations for response evaluation
Time frame: PET MRI performed at baseline (15 days before the treatment beginning) less than one month before the surgery
Comparison of the accuracies of PT MRI and CT for resectability assessment
Time frame: CT and PET MRI performed less than one month before the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Mathilde WAGNER, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MRI in people with Pancreatic Adenocarcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Jul 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathilde WAGNER, MD, PhD (0033142178305, mathilde.wagner@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of PET/MRI to predict pancreatic adenocarcinoma rescetability after neaadjuvant treatment (time frame: PET/MRI performed less than one month before the surgery). 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 26 Jul 2017.