Metastatic Colorectal CancerPhase 2iTEP ColonNCT02587247
ImmunoTEP With 68-Ga in Metastatic Colo Rectal Cancer
A Phase 2 study testing TF2 antibody/68Ga-IMP-288 in people with Metastatic Colorectal Cancer, run by Nantes University Hospital at 2 sites in France.
Trial summary
Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging potential candidate patients for surgery of local resection of one or more metastases at diagnosis or during relapse CCR expressing CEA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- TF2 antibody/68Ga-IMP-288
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2016to Jan 2017
- 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
- Existence of one or more metastases of of colorectal cancer (CRC) expressing the CEA , potentially accessible by surgical or thermo resection at the moment of the diagnosis or at relapse.
- OR
- Isolated and progressive elevation of plasma CEA during the monitoring of CRC with high metastatic risk
- More than 18 years
- Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective continuous contraception for 3 months.
- At least 4 weeks after the last treatment and after recovery of potential toxicity
Show all 12Show fewer
- Karnofsky more than 70 or ECOG 0-1
- Life expectancy of at least 6 months
- CEA positive immunohistochemistry or plasma CEA supperior or equal to the normal level
- Creatinin less or equal 200 micromol/L
- Signed informed consent
- geographical proximity
Who cannot join
- Pregnancy or breastfeeding
- Serious illness or comorbidity assessed risk
- History of other cancer within 5 years, with the exception of skin carcinomas other than melanomas or in-situ carcinoma of the cervix
- Anti-antibody presence in patients who have already received antibody
- Hypersensitivity to antibodies or proteins
- Intellectual inability to sign the informed consent
- Insulin-dependent diabetic patient or non-insulin dependent
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU
Nantes, 44093
Institut de cancérologie de l'Ouest
Saint-Herblain, 44805
About this study
Official title: Apport de l'Immuno-TEP préciblée Avec l'Anticorps bispécifique Anti-ACE x Anti-HSG TF2 et le Peptide IMP-288 marqué au Gallium-68 Pour l'Imagerie Des Patients Potentiellement Candidats à Une Chirurgie d'exérèse et/ou Thermoablation Locale d'Une ou Plusieurs métastases, au Diagnostic ou Lors de la Rechute de Cancers Colo-rectaux (CCR) Exprimant l'antigène Carcino-embryonnaire (ACE): Comparaison au Bilan Conventionnel
Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging potential candidate patients for surgery of local resection of one or more metastases at diagnosis or during relapse CCR expressing CEA.
Read the detailed description
Injection of a bispecific anti-CEA x anti-HSG antibody TF2 (120 nmoles) and 30 hours later IMP-288 peptide labeled with gallium-68 (3 to 6 nmoles/150 MBq). A TEP imaging acquisition is plannified 60 min after the 68-Ga injection.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- TF2 antibody/68Ga-IMP-288
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TF2 antibody/68Ga-IMP-288Drug
TF2 antibody coupled with 68Ga-IMP-288
| Study group | Role | What they receive |
|---|---|---|
| TF2 antibody/68Ga-IMP-288 | Experimental | TF2 antibody/68Ga-IMP-288 Receives: Drug: TF2 antibody/68Ga-IMP-288 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68
Initial and M3 imaging assessment comparaison, and/or immunohistochemistry
Measured: Month 3
Secondary outcomes (6)
To compare the diagnostic performance of immuno-PET with morphological and functional imaging procedures currently performed in the imaging assessment (CT, ultrasound + liver MRI, FDG-PET).
Identified lesions at initial and M3 imaging assessment will be compared with lesions identified with 68-Ga-PET
Measured: Month 3
To Determine the value of immuno-PET in terms of specificity and predictive value. This determination will be made at the "patient" and at the "injury level.
Comparaison with baseline imaging assessment, Month 3 imaging and/or immunohistochemistry evaluation
Measured: Month 3
To assess the safety of the procedure
Biological and clinical examen of the patients between Day 1 and month 3 follow up. The assement will be according to NCI criteria
Measured: Month 3
Search for the development of a blood Immunization against the products
Human anti Human antibody test by immuno assay at base line, M1 and M3
Measured: Month 3
To study the expression of CEA intensity on surgical excision parts in surgical patients and compare it to the semi-quantitative immuno-PET
Immunohistochemistry analysis with anti CEA antibody
Measured: No more than 3 months (it depend of the day of the surgery)
To evaluate the clinical impact (new lecture of imaging, new examens)
A form will be fill in by the physican who request the immuno PET
Measured: M1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startMar 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587247
- Sponsor's protocol ID
- RC14_0428
- Acronym
- iTEP Colon
- Status last verified
- Jul 2022
- First submitted
- 19 Oct 2015
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Touchefeu Y, Bailly C, Frampas E, Eugene T, Rousseau C, Bourgeois M, Bossard C, Faivre-Chauvet A, Rauscher A, Masson D, David A, Cerato E, Carlier T, Sharkey RM, Goldenberg DM, Barbet J, Kraeber-Bodere F, Bodet-Milin C. Promising clinical performance of pretargeted immuno-PET with anti-CEA bispecific antibody and gallium-68-labelled IMP-288 peptide for imaging colorectal cancer metastases: a pilot study. Eur J Nucl Med Mol Imaging. 2021 Mar;48(3):874-882. doi: 10.1007/s00259-020-04989-3. Epub 2020 Aug 21.
PubMed 32820369
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apport de l'Immuno-TEP préciblée Avec l'Anticorps bispécifique Anti-ACE x Anti-HSG TF2 et le Peptide IMP-288 marqué au Gallium-68 Pour l'Imagerie Des Patients Potentiellement Candidats à Une Chirurgie d'exérèse et/ou Thermoablation Locale d'Une ou Plusieurs métastases, au Diagnostic ou Lors de la Rechute de Cancers Colo-rectaux (CCR) Exprimant l'antigène Carcino-embryonnaire (ACE): Comparaison au Bilan Conventionnel
- ClinicalTrials.gov ID
- NCT02587247
- Acronym / sponsor ID
- iTEP Colon / RC14_0428
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Oct 2015 (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.
Evaluation of the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 for imaging potential candidate patients for surgery of local resection of one or more metastases at diagnosis or during relapse CCR expressing CEA.
Detailed description
Injection of a bispecific anti-CEA x anti-HSG antibody TF2 (120 nmoles) and 30 hours later IMP-288 peptide labeled with gallium-68 (3 to 6 nmoles/150 MBq). A TEP imaging acquisition is plannified 60 min after the 68-Ga injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TF2 antibody/68Ga-IMP-288 | Experimental | Drug: TF2 antibody/68Ga-IMP-288TF2 antibody/68Ga-IMP-288 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Existence of one or more metastases of of colorectal cancer (CRC) expressing the CEA , potentially accessible by surgical or thermo resection at the moment of the diagnosis or at relapse.
- OR
- Isolated and progressive elevation of plasma CEA during the monitoring of CRC with high metastatic risk
- More than 18 years
- Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective continuous contraception for 3 months.
Key exclusion criteria (7 listed)
- Pregnancy or breastfeeding
- Serious illness or comorbidity assessed risk
- History of other cancer within 5 years, with the exception of skin carcinomas other than melanomas or in-situ carcinoma of the cervix
- Anti-antibody presence in patients who have already received antibody
- Hypersensitivity to antibodies or proteins
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 |
|---|---|---|
| TF2 antibody/68Ga-IMP-288TF2 antibody coupled with 68Ga-IMP-288 | Drug | TF2 antibody/68Ga-IMP-288 |
Primary outcome
Evaluate the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68
Time frame: Month 3
Initial and M3 imaging assessment comparaison, and/or immunohistochemistry
6 secondary outcomes
To compare the diagnostic performance of immuno-PET with morphological and functional imaging procedures currently performed in the imaging assessment (CT, ultrasound + liver MRI, FDG-PET).
Time frame: Month 3
To Determine the value of immuno-PET in terms of specificity and predictive value. This determination will be made at the "patient" and at the "injury level.
Time frame: Month 3
To assess the safety of the procedure
Time frame: Month 3
Search for the development of a blood Immunization against the products
Time frame: Month 3
To study the expression of CEA intensity on surgical excision parts in surgical patients and compare it to the semi-quantitative immuno-PET
Time frame: No more than 3 months (it depend of the day of the surgery)
To evaluate the clinical impact (new lecture of imaging, new examens)
Time frame: M1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 32820369Touchefeu Y, Bailly C, Frampas E, Eugene T, Rousseau C, Bourgeois M, Bossard C, Faivre-Chauvet A, Rauscher A, Masson D, David A, Cerato E, Carlier T, Sharkey RM, Goldenberg DM, Barbet J, Kraeber-Bodere F, Bodet-Milin C. Promising clinical performance of pretargeted immuno-PET with anti-CEA bispecific antibody and gallium-68-labelled IMP-288 peptide for imaging colorectal cancer metastases: a pilot study. Eur J Nucl Med Mol Imaging. 2021 Mar;48(3):874-882. doi: 10.1007/s00259-020-04989-3. Epub 2020 Aug 21.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TF2 antibody/68Ga-IMP-288 in people with Metastatic Colorectal Cancer, run by Nantes University Hospital at 2 sites 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 7 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the sensitivity of the immuno-PET PET / CT pretargeted with the bispecific anti-CEA x anti-HSG TF2 antibody and IMP-288 peptide labeled with Gallium-68 (time frame: Month 3). 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 NCT02587247, which also lists 1 linked publication.
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 14 Sep 2026.