NCT02325349

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2015

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 20, 2015

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3.5 years

First QC Date

December 7, 2014

Last Update Submit

July 18, 2022

Conditions

Advanced Head and Neck CarcinomaAdvanced Non-small Cell Lung Carcinoma

Keywords

AngiogenesisIntegrinsRGD PET/CTFDG PET/CTPredictive valueTherapeutic responseEfficacyTolerability

Outcome Measures

Primary Outcomes (1)

  • 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

    Pretherapeutic Day-14, Interim Day21

Study Arms (1)

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)

Drug: radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)

Interventions

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)

radiopharmaceutical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A. 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
  • B. Male or female \> 18year old with head and neck (H\&N) cancer meeting the following criteria:
  • 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.

You may not qualify if:

  • \- 1. In patients with lung cancer: lung cancer with predominance of small-cell or pure bronchioloalveolar cancer.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Tenon - Assistance Publique-Hôpitaux de Paris

Paris, 75020, France

Location

MeSH Terms

Interventions

Radiopharmaceuticals

Intervention Hierarchy (Ancestors)

Diagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesMolecular Mechanisms of Pharmacological ActionIndicators and ReagentsLaboratory ChemicalsSpecialty Uses of Chemicals

Study Officials

  • Sona BALOGOVA

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2014

First Posted

December 25, 2014

Study Start

March 20, 2015

Primary Completion

September 20, 2018

Study Completion

September 20, 2018

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

FR(1)