Advanced Head and Neck CarcinomaPhase 2MLAPOCHINCT02325349
PET/CT Imaging of Angiogenesis in Lung or Head and Neck Cancers Prior or During Chemotherapy With Antiangiogenic Agents
A Phase 2 study testing radiopharmaceutical (Flotegatide (18F) or RGD (68Ga) in people with Advanced Head and Neck Carcinoma and Advanced Non-small Cell Lung Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with antiangiogenic effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Head and Neck Carcinoma, Advanced Non-small Cell Lung Carcinoma
- What is being tested?
- radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2015to 20 Sep 2018
- Phase
- Phase 2
- 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
- 1A. Male or female > 18year old with non-small cell lung carcinoma (NSCLC) meeting the following criteria :
- advanced NSCLC proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled
- Measurable lesions > 1 cm in short axis.
- Pretherapeutic contrast-enhanced CT of thorax and upper abdomen available for masked reading on appropriate medium
- FDG PET/CT available for masked reading on appropriate medium
- 1B. Male or female > 18year old with head and neck (H\&N) cancer meeting the following criteria:
Show all 12Show fewer
- advanced H\&N cancer proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled
- Measurable lesions > 1 cm in short axis.
- Pretherapeutic native and contrast enhanced CT or MRI of the head and neck available for masked reading on appropriate medium
- FDG PET/CT available for masked reading on appropriate medium
- Oto-rhino-laryngologic (ORL) examination including ORL fibroscopy and/or optionally panendoscopy.
- 2. Capacity to remain without movement during the PET/CT examination 3. ECOG performance status ≤ 2 at inclusion 4. Patient with life expectancy ≥ 24 weeks after inclusion. 5. In fertile females, at inclusion the pregnancy must be ruled out 6. Volunteer and capable to follow necessary instructions during the trial 7. Informed consent signed by the patient 8. Affiliation to a social security system
Who cannot join
- 1. In patients with lung cancer: lung cancer with predominance of small-cell or pure bronchioloalveolar cancer.
- 2. Scheduled treatment which does not include an antiangiogenic agent 3. Patient´s physical condition not permitting participation it clinical trial according to opinion of investigator responsible of the centre 4. Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Tenon - Assistance Publique-Hôpitaux de Paris
Paris, 75020
About this study
Official title: PET/CT Molecular Imaging of Angiogenesis in Pulmonary or Head and Neck Cancers Prior to or During Chemotherapy Including Agent With Antiangiogenic Effect. A Prospective Multicentric Study of Efficacy and Tolerability.
The primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with antiangiogenic effect.
The predictive value of this approach will be determined by independent assessors on basis of data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for FDG PET/CT, clinical, endoscopic and histological findings.
Read the detailed description
Prospective, multicentre, open label, phase II clinical trial with diagnostic radiopharmaceutical on efficacy and tolerability of 18F or 68Ga labelled RGD peptide for detection of malignant tissues expressing integrins, to predict the therapeutic response of lesions of advanced head and neck cancer or advanced non-small cells lung cancer to treatment including an agent with antiangiogenic effect.
- Being tested
- radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)
- Keywords
- Angiogenesis, Integrins, RGD PET/CT, FDG PET/CT, Predictive value, Therapeutic response, Efficacy, Tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)Drug
PET/CT after intravenous administration of 2-4MBq/kg of body weight of Flotegatide (18F) or RGD (68Ga) performed prior and after 2 cycles of chemotherapy including an agent with antiangiogenic effect (two examinations in each patient)
| Study group | Role | What they receive |
|---|---|---|
| radiopharmaceutical | Experimental | PET/CT after intravenous administration of 2-4MBq/kg of body weight of Flotegatide (18F) or RGD (68Ga) performed prior and after 2 cycles of chemotherapy including an agent with antiangiogenic effect (two examinations in each patient) Receives: Drug: radiopharmaceutical (Flotegatide (18F) or RGD (68Ga) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment based on RECIST criterion
The value of pretherapeutic and interim RGD PET/CT (Pretherapeutic: D -14 to -1 before the initiation of chemotherapy with antiangiogenic agent. Interim : 21 to 1 day before the third cycle of chemotherapy with antiangiogenic agent) to early predict the therapeutic response of head and neck cancer or non-small cell lung cancer to chemotherapy with antiangiogenic agent. Final therapeutic response will be assessed at the end of the treatment, up to 24 weeks after first examination, according to criteria RECIST 1.1.
Potential risk for the patient: two intravenous administrations of investigational product (Pretherapeutic : D -14 to -1 before the initiation of chemotherapy with antiangiogenic agent. Interim : 21 to 1 day before the third cycle of chemotherapy with antiangiogenic agent) each of them followed by PET/CT acquisition
Measured: Pretherapeutic Day-14, Interim Day21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study start20 Mar 2015
- Primary completion20 Sep 2018
- Study completion20 Sep 2018
Why it stopped: Change in protocol strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Head and Neck CarcinomaStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sona BALOGOVA, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325349
- Sponsor's protocol ID
- P110154
- Other IDs
- 2014-000553-37, 2014
- Acronym
- MLAPOCHI
- Status last verified
- Jul 2022
- First submitted
- 7 Dec 2014
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/CT Molecular Imaging of Angiogenesis in Pulmonary or Head and Neck Cancers Prior to or During Chemotherapy Including Agent With Antiangiogenic Effect. A Prospective Multicentric Study of Efficacy and Tolerability.
- ClinicalTrials.gov ID
- NCT02325349
- Acronym / sponsor ID
- MLAPOCHI / P110154
- Keywords
- Angiogenesis, Integrins, RGD PET/CT, FDG PET/CT, Predictive value, Therapeutic response, Efficacy, Tolerability
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in protocol strategy
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Mar 2015 (actual)
- Primary completion
- 20 Sep 2018 (actual)
- Study completion
- 20 Sep 2018 (actual)
- First posted
- 25 Dec 2014 (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 primary objective of this Phase II study is to evaluate the use of labelled RGD ligand in PET/CT to predict and/or to early assess the efficacy of chemotherapy including an agent with antiangiogenic effect.
The predictive value of this approach will be determined by independent assessors on basis of data at the end of the treatment: RECIST 1.1 criteria for CT or MRI, PERCIST criteria for FDG PET/CT, clinical, endoscopic and histological findings.
Detailed description
Prospective, multicentre, open label, phase II clinical trial with diagnostic radiopharmaceutical on efficacy and tolerability of 18F or 68Ga labelled RGD peptide for detection of malignant tissues expressing integrins, to predict the therapeutic response of lesions of advanced head and neck cancer or advanced non-small cells lung cancer to treatment including an agent with antiangiogenic effect.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| radiopharmaceutical | Experimental | Drug: radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)PET/CT after intravenous administration of 2-4MBq/kg of body weight of Flotegatide (18F) or RGD (68Ga) performed prior and after 2 cycles of chemotherapy including an agent with antiangiogenic effect (two examinations in each patient) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1A. Male or female > 18year old with non-small cell lung carcinoma (NSCLC) meeting the following criteria :
- advanced NSCLC proven by histology or cytology, treatment including an agent with antiangiogenic effect scheduled
- Measurable lesions > 1 cm in short axis.
- Pretherapeutic contrast-enhanced CT of thorax and upper abdomen available for masked reading on appropriate medium
- FDG PET/CT available for masked reading on appropriate medium
Key exclusion criteria (2 listed)
- 1. In patients with lung cancer: lung cancer with predominance of small-cell or pure bronchioloalveolar cancer.
- 2. Scheduled treatment which does not include an antiangiogenic agent 3. Patient´s physical condition not permitting participation it clinical trial according to opinion of investigator responsible of the centre 4. Pregnancy or breastfeeding.
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 |
|---|---|---|
| radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)PET/CT after intravenous administration of 2-4MBq/kg of body weight of Flotegatide (18F) or RGD (68Ga) performed prior and after 2 cycles of chemotherapy including an agent with antiangiogenic effect (two examinations in each patient) | Drug | radiopharmaceutical |
Primary outcome
Response to treatment based on RECIST criterion
Time frame: Pretherapeutic Day-14, Interim Day21
The value of pretherapeutic and interim RGD PET/CT (Pretherapeutic: D -14 to -1 before the initiation of chemotherapy with antiangiogenic agent. Interim : 21 to 1 day before the third cycle of chemotherapy with antiangiogenic agent) to early predict the therapeutic response of head and neck cancer or non-small cell lung cancer to chemotherapy with antiangiogenic agent. Final therapeutic response will be assessed at the end of the treatment, up to 24 weeks after first examination, according to criteria RECIST 1.1. Potential risk for the patient: two intravenous administrations of investigational product (Pretherapeutic : D -14 to -1 before the initiation of chemotherapy with antiangiogenic agent. Interim : 21 to 1 day before the third cycle of chemotherapy with antiangiogenic agent) each of them followed by PET/CT acquisition
Results and safety
The study was stopped early (reason given: Change in protocol strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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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.
Sona BALOGOVA 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 Phase 2 study testing radiopharmaceutical (Flotegatide (18F) or RGD (68Ga) in people with Advanced Head and Neck Carcinoma and Advanced Non-small Cell Lung Carcinoma, 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 12 inclusion and 2 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 19 Jul 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Change in protocol strategy). 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?
Response to treatment based on RECIST criterion (time frame: Pretherapeutic Day-14, Interim Day21). 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 19 Jul 2022.