Back to results18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma (FDG-IMMUN)
Primary Purpose
Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
18FDG PET
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
Eligibility Criteria
Inclusion Criteria:
- Age > or = 18 years,
- Patients with unresectable melanoma or histologically proven, metastatic or locally advanced NSCLC,
- Indication of an immunotherapy treatment with nivolumab or pembrolizumab validated in multidisciplinary consultation team and prescribed as part of their marketing authorization, in first or second line of treatment,
- Performance Status 0 to 2,
- Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required,
- Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year,
- Male subjects should agree to use an adequate method of contraception or abstain from heterosexual activity starting with the first dose of study therapy through 6 months after the last dose of study therapy,
- Patient willing and able to provide written informed consent/assent for the trial,
- Patient affiliated with a health insurance system.
Exclusion Criteria:
- Age < 18 years,
- Contraindication to performing 18FDG PET scans: severe claustrophobia, unbalanced diabetes during PET examinations (fasting capillary blood glucose ≥ 11 mmol),
- Any participation in other biomedical studies related to the drug, medical devices or imaging techniques is prohibited except biomedical studies called overstudies (In case of doubt or questions about the patient's participation in a other clinical study, please contact the sponsor),
- Contraindication to nivolumab or pembrolizumab treatment,
- Patient with metastatic disease,
- History of thoracic irradiation or near / in the thoracic irradiation field,
- Patient who refuses to participate in the study or unable to agree,
- Patient currently receiving one or more treatments described in section 6.9 of the protocol,
- Contraindication to nivolumab or pembrolizumab treatment,
- People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside a state to express their consent, pregnant or breastfeeding women.
Sites / Locations
- Centre Antoine LacassagneRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
18FDG PET
Arm Description
Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
Outcomes
Primary Outcome Measures
Threshold of the 18FDG retention index (dual-point acquisition), from the first metabolic progression observed in 18FDG PET, to distinguish a true tumor progression from a pseudo-progression of inflammatory origin (leukocyte infiltrate)
ROC curve of the FDG retention index, defined on the dual-point PET acquisition, will be analysed to distinguish lesions in true progressions and lesions in inflammatory pseudo-progressions.
Secondary Outcome Measures
PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions
It will be measured with absolute SUVpeak of new hyperfixing lesions
PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions
It will be measured with Percent change in fixation intensity of pre-existing lesions
PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions
It will be measured with Percentage of change in lesional tumor volume
PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions
It will be measured with Percentage of change in total Total Lesion
The incidence of inflammatory pseudo-progression compared to true tumor progressions, taking into account the impact of the primary tumor
Evaluation of the ratio between the lesions with an inflammatory pseudo-progression and those with a true tumor progression will be measured. A lesion and patient analysis will be performed
The incidence of inflammatory or infectious lesions diagnosed by 18FDG PET and their impact on clinical management
Frequency of inflammatory or infectious lesions accidentally diagnosed by PET will be measured
The incidence of inflammatory or infectious lesions diagnosed by 18FDG PET and their impact on clinical management
The number of these inflammatory diagnoses leading to specific management will be measured
The predictive value of the early metabolic response at 7 weeks on the morphological
Measurement of the association will be assessed with the early metabolic response at 7 weeks . The metabolic response will be evaluated according to PERCIST criteria.
The predictive value of the early metabolic response on metabolic responses at 3 months
Measurement of the association will be assessed with the morphological response at 3 months. The morphological response will be evaluated according to RECIST criteria v1.1 and i-RECIST in patients who have received the injection of iodine contrast product in PET scan
The prognostic value of the 7-week PET metabolic response on 12-month overall survival
To determine the delay between the date of inclusion and the date of death, overall survival will be measured at 12 months according to the changes in tumor metabolism on the interim PET at 7 weeks.
The prognostic value of the 3-month PET metabolic response on 12-month overall survival
To determine the delay between the date of inclusion and the date of death, overall survival will be measured at 12 months according to the changes in tumor metabolism on the interim PET at 3 months.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03584334
Brief Title
18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
Acronym
FDG-IMMUN
Official Title
Cohort Study Evaluating 18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2019 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The hypothesis of this diagnostic performance study is that, for patients treated for immunotherapy-treated melanoma or NSCLC, some metabolic parameters of the 18FDG dual-point PET scan distinguish inflammatory pseudo-progression from tumor progression true and thus improve the evaluation of tumor response to immunotherapy
Detailed Description
The originality of this study is based on the stakes of the early prediction of resistance to immunotherapy (early therapeutic escapes, side effects, cost of treatment etc.).
No prospective study has been published to date on the value of 18FDG PET to distinguish between true tumor progression and pseudo-progression. Studies are therefore needed to define new criteria for evaluating the metabolic response specific to immunotherapy, as well as the optimal timing of the interim examination.
The goal is to conduct a transversal, non-randomized, prospective, multi-center, diagnostic performance study, harmonizing the moments of the 18FDG PET scans, acquisition conditions and interpretation criteria. The use of a dual-point acquisition in PET will also make it possible to judge the kinetics of 18FDG lesion capture (calculation of the 18FDG retention index on the late image) with the objective of highlighting PET criteria to distinguish between inflammatory pseudo-progression and true tumor progression in patients with unresectable melanoma or advanced or metastatic NSCLC. Other metabolic parameters will be studied, such as changes in tumor metabolic volume and binding intensities.
Finally, this study will include patients to assess the correlation between the metabolic tumor response observed after 7 weeks of immunotherapy, the morphological response after 3 months of treatment (RECIST v1.1 and i-RECIST) and survival overall at 1 year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective non-randomized, multi-center, diagnostic performance study of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18FDG PET
Arm Type
Other
Arm Description
Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
Intervention Type
Radiation
Intervention Name(s)
18FDG PET
Intervention Description
Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
Primary Outcome Measure Information:
Title
Threshold of the 18FDG retention index (dual-point acquisition), from the first metabolic progression observed in 18FDG PET, to distinguish a true tumor progression from a pseudo-progression of inflammatory origin (leukocyte infiltrate)
Description
ROC curve of the FDG retention index, defined on the dual-point PET acquisition, will be analysed to distinguish lesions in true progressions and lesions in inflammatory pseudo-progressions.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions
Description
It will be measured with absolute SUVpeak of new hyperfixing lesions
Time Frame
12 months
Title
PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions
Description
It will be measured with Percent change in fixation intensity of pre-existing lesions
Time Frame
12 months
Title
PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions
Description
It will be measured with Percentage of change in lesional tumor volume
Time Frame
12 months
Title
PET criteria other than the 18FDG retention index to distinguish pseudo-progressions from true tumor progressions for new lesions: intensity of fixation (SUVpeak) and location of new lesions
Description
It will be measured with Percentage of change in total Total Lesion
Time Frame
12 months
Title
The incidence of inflammatory pseudo-progression compared to true tumor progressions, taking into account the impact of the primary tumor
Description
Evaluation of the ratio between the lesions with an inflammatory pseudo-progression and those with a true tumor progression will be measured. A lesion and patient analysis will be performed
Time Frame
12 months
Title
The incidence of inflammatory or infectious lesions diagnosed by 18FDG PET and their impact on clinical management
Description
Frequency of inflammatory or infectious lesions accidentally diagnosed by PET will be measured
Time Frame
12 months
Title
The incidence of inflammatory or infectious lesions diagnosed by 18FDG PET and their impact on clinical management
Description
The number of these inflammatory diagnoses leading to specific management will be measured
Time Frame
12 months
Title
The predictive value of the early metabolic response at 7 weeks on the morphological
Description
Measurement of the association will be assessed with the early metabolic response at 7 weeks . The metabolic response will be evaluated according to PERCIST criteria.
Time Frame
3 months
Title
The predictive value of the early metabolic response on metabolic responses at 3 months
Description
Measurement of the association will be assessed with the morphological response at 3 months. The morphological response will be evaluated according to RECIST criteria v1.1 and i-RECIST in patients who have received the injection of iodine contrast product in PET scan
Time Frame
3 months
Title
The prognostic value of the 7-week PET metabolic response on 12-month overall survival
Description
To determine the delay between the date of inclusion and the date of death, overall survival will be measured at 12 months according to the changes in tumor metabolism on the interim PET at 7 weeks.
Time Frame
12 months
Title
The prognostic value of the 3-month PET metabolic response on 12-month overall survival
Description
To determine the delay between the date of inclusion and the date of death, overall survival will be measured at 12 months according to the changes in tumor metabolism on the interim PET at 3 months.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > or = 18 years,
Patients with unresectable melanoma or histologically proven, metastatic or locally advanced NSCLC,
Indication of an immunotherapy treatment with nivolumab or pembrolizumab validated in multidisciplinary consultation team and prescribed as part of their marketing authorization, in first or second line of treatment,
Performance Status 0 to 2,
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required,
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year,
Male subjects should agree to use an adequate method of contraception or abstain from heterosexual activity starting with the first dose of study therapy through 6 months after the last dose of study therapy,
Patient willing and able to provide written informed consent/assent for the trial,
Patient affiliated with a health insurance system.
Exclusion Criteria:
Age < 18 years,
Contraindication to performing 18FDG PET scans: severe claustrophobia, unbalanced diabetes during PET examinations (fasting capillary blood glucose ≥ 11 mmol),
Any participation in other biomedical studies related to the drug, medical devices or imaging techniques is prohibited except biomedical studies called overstudies (In case of doubt or questions about the patient's participation in a other clinical study, please contact the sponsor),
Contraindication to nivolumab or pembrolizumab treatment,
Patient with metastatic disease,
History of thoracic irradiation or near / in the thoracic irradiation field,
Patient who refuses to participate in the study or unable to agree,
Patient currently receiving one or more treatments described in section 6.9 of the protocol,
Contraindication to nivolumab or pembrolizumab treatment,
People particularly vulnerable as defined in Articles L.1121-5 to -8 of the French Healthcare Code, including: person deprived of freedom by an administrative or judicial decision, adult being the object of a legal protection measure or outside a state to express their consent, pregnant or breastfeeding women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
OLIVIER HUMBERT, PHD
Phone
+33492031310
Email
olivier.humbert@nice.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jacques DARCOURT, PHD
Phone
+33492031098
Email
jacques.darcourt@nice.unicancer.fr
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier HUMBERT, MD
Phone
+3 34 92 03 1778
Email
olivier.humbert@nice.unicancer.fr
12. IPD Sharing Statement
Learn more about this trial
18FDG PET for Early Identification of Tumor Exhaust for Immunotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Bronchopulmonary Carcinoma or Melanoma
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