Colorectal NeoplasmPhase 2NCT00001568
Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities
A Phase 2 study testing 2-Fluoro-2-deoxyglucose in people with Colorectal Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50 mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min. Initial dynamic images will be obtained over the heart. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- 2-Fluoro-2-deoxyglucose
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1997to Oct 2002
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
All patients greater than 18 years old who have had a prior resection of colorectal cancer and are suspected of having recurrent disease.
Rising serum CEA levels greater than 6 on two successive tests.
Resectable residual or recurrent disease. Patients in the occult arm (Arm 1) must have no visible residual disease in the abdomen at the time of the last surgical exploration. In addition, there must be no imageable definitive site of recurrent disease using conventional imaging modalities including; CT scan of chest/ abdomen/ pelvis with contrast, MRI scan, and chest x-ray. Patients in arm 2 may have a single site of recurrent or metastatic disease which is resectable but in whom additional sites of disease are not known and no imageable disease other than a solitary site of potentially resectable disease is identified.
Patients must have an ECOG performance status of 0-1.
Patients must be willing to return to NIH for follow-up.
Patients must be able to provide informed consent as demonstrated by the signed consent.
Patients must be 2 or more months from abdominal or thoracic surgery.
No patients with medical contraindication to abdominal exploration.
No patients with recurrent disease detected by conventional imaging studies as outlined above. Metastatic disease localized outside of the abdominal cavity by conventional imaging studies as outlined above. Patients must weigh less than 136 kgs. which is the weight limit for the scanner tables.
No patients with previous injection of murine monoclonal antibodies: Human anti-mouse assay (HAMA) will be performed in patients with prior history of receiving murine monoclonal antibodies.
No patients that are pregnant or breast feeding.
Patients who are HIV + will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50 mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min. Initial dynamic images will be obtained over the heart. Emission imaging will work from the midcervical region down to the perineal region.
For CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over 5 min. A single photon emission computed tomography (SPECT) transmission scan is performed over the same regions as the emission scans. Total dose from transmission scans should be no more than 20 mRad per patient visit.
Read more
Patients then undergo exploratory laparotomy performed by two surgeons, one blinded to the results of the CEA-Scan and PET scan.
At the completion of all exploration, all identified disease is biopsied for pathologic analysis and any resectable disease is removed.
Patients are followed every 3 months for 1 year, every 6 months for the second year, and then after 3 years.
Read the detailed description
Recurrences following resection for colorectal carcinoma occur in 50% of patients. Early detection and management of recurrences results in improved survival. Post-operative surveillance consists of serial CT scans, chest x-rays, colonoscopy and CEA determinations. Elevations in the serum CEA level can be the earliest and most sensitive indicator of recurrence. A rise in the serum CEA level in the absence of imageable disease presents a particular diagnostic challenge. Advanced imaging modalities such as Positron Emission Tomography (PET) and anti-CEA antibody immunoscintigraphy have been proposed as a way of localizing disease in these patients. This study will evaluate the sensitivity, specificity, accuracy and predictive value of FDG-PET scans and anti-CEA immunoscintigraphy in patients following resection of colorectal carcinoma who have rising serum CEA values in the absence of imageable disease by conventional modalities. Patients who meet inclusion criteria will undergo FDG-PET scan and anti-CEA immunoscintigraphy followed by an exploratory laparotomy. Abdominal explorations will be conducted by two surgeons, one of whom will be blinded to the results of the FDG-PET and CEA scans. All suspicious lesions will be biopsied and if possible resected. Results at operation will be correlated with the results of the scans. The goal of the study is to determine the role of FDG-PET scanning and anti-CEA immunoscintigraphy in the localization of recurrent colorectal carcinoma in patients with rising serum CEA levels.
- Conditions
- Colorectal Neoplasm
- Being tested
- 2-Fluoro-2-deoxyglucose
- Keywords
- Tumors, Detection, Follow-Up, Markers, Radiolabeled
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-Fluoro-2-deoxyglucoseDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startFeb 1997
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Treatment
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001568
- Sponsor's protocol ID
- 970068
- Other IDs
- 97-C-0068
- Status last verified
- Oct 2002
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Minton JP, Hoehn JL, Gerber DM, Horsley JS, Connolly DP, Salwan F, Fletcher WS, Cruz AB Jr, Gatchell FG, Oviedo M, et al. Results of a 400-patient carcinoembryonic antigen second-look colorectal cancer study. Cancer. 1985 Mar 15;55(6):1284-90. doi: 10.1002/1097-0142(19850315)55:63.0.co;2-b.
PubMed 3971297Moffat FL Jr, Pinsky CM, Hammershaimb L, Petrelli NJ, Patt YZ, Whaley FS, Goldenberg DM. Clinical utility of external immunoscintigraphy with the IMMU-4 technetium-99m Fab' antibody fragment in patients undergoing surgery for carcinoma of the colon and rectum: results of a pivotal, phase III trial. The Immunomedics Study Group. J Clin Oncol. 1996 Aug;14(8):2295-305. doi: 10.1200/JCO.1996.14.8.2295.
PubMed 8708720Sardi A, Agnone CM, Nieroda CA, Mojzisik C, Hinkle G, Ferrara P, Farrar WB, Bolton J, Thurston MO, Martin EW Jr. Radioimmunoguided surgery in recurrent colorectal cancer: the role of carcinoembryonic antigen, computerized tomography, and physical examination. South Med J. 1989 Oct;82(10):1235-44.
PubMed 2799440
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Role of Anti-CEA Antibody Immunoscintigraphy & Positron Emission Tomography in the Localization of Recurrent Colorectal Carcinoma in Patients With Rising Serum CEA Levels in the Absence of Imageable Disease by Conventional Modalities
- ClinicalTrials.gov ID
- NCT00001568
- Acronym / sponsor ID
- 970068
- Conditions
- Colorectal Neoplasm
- Keywords
- Tumors, Detection, Follow-Up, Markers, Radiolabeled
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 1997
- Study completion
- Oct 2002
- First posted
- 4 Nov 1999 (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.
Positron Emission Tomography (PET scanning) is performed using a total dose of less than 50 mRad per patient visit. Fludeoxyglucose F 18 (FDG) is injected intravenously over 2 min. Initial dynamic images will be obtained over the heart. Emission imaging will work from the midcervical region down to the perineal region.
For CEA scanning, radiolabeled antibody, arcitumomab (IMMU-4), is injected intravenously over 5 min. A single photon emission computed tomography (SPECT) transmission scan is performed over the same regions as the emission scans. Total dose from transmission scans should be no more than 20 mRad per patient visit.
Patients then undergo exploratory laparotomy performed by two surgeons, one blinded to the results of the CEA-Scan and PET scan.
At the completion of all exploration, all identified disease is biopsied for pathologic analysis and any resectable disease is removed.
Patients are followed every 3 months for 1 year, every 6 months for the second year, and then after 3 years.
Detailed description
Recurrences following resection for colorectal carcinoma occur in 50% of patients. Early detection and management of recurrences results in improved survival. Post-operative surveillance consists of serial CT scans, chest x-rays, colonoscopy and CEA determinations. Elevations in the serum CEA level can be the earliest and most sensitive indicator of recurrence. A rise in the serum CEA level in the absence of imageable disease presents a particular diagnostic challenge. Advanced imaging modalities such as Positron Emission Tomography (PET) and anti-CEA antibody immunoscintigraphy have been proposed as a way of localizing disease in these patients. This study will evaluate the sensitivity, specificity, accuracy and predictive value of FDG-PET scans and anti-CEA immunoscintigraphy in patients following resection of colorectal carcinoma who have rising serum CEA values in the absence of imageable disease by conventional modalities. Patients who meet inclusion criteria will undergo FDG-PET scan and anti-CEA immunoscintigraphy followed by an exploratory laparotomy. Abdominal explorations will be conducted by two surgeons, one of whom will be blinded to the results of the FDG-PET and CEA scans. All suspicious lesions will be biopsied and if possible resected. Results at operation will be correlated with the results of the scans. The goal of the study is to determine the role of FDG-PET scanning and anti-CEA immunoscintigraphy in the localization of recurrent colorectal carcinoma in patients with rising serum CEA levels.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| 2-Fluoro-2-deoxyglucose | Drug | – |
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 3971297Minton JP, Hoehn JL, Gerber DM, Horsley JS, Connolly DP, Salwan F, Fletcher WS, Cruz AB Jr, Gatchell FG, Oviedo M, et al. Results of a 400-patient carcinoembryonic antigen second-look colorectal cancer study. Cancer. 1985 Mar 15;55(6):1284-90. doi: 10.1002/1097-0142(19850315)55:63.0.co;2-b.
- Background: PubMed 8708720Moffat FL Jr, Pinsky CM, Hammershaimb L, Petrelli NJ, Patt YZ, Whaley FS, Goldenberg DM. Clinical utility of external immunoscintigraphy with the IMMU-4 technetium-99m Fab' antibody fragment in patients undergoing surgery for carcinoma of the colon and rectum: results of a pivotal, phase III trial. The Immunomedics Study Group. J Clin Oncol. 1996 Aug;14(8):2295-305. doi: 10.1200/JCO.1996.14.8.2295.
- Background: PubMed 2799440Sardi A, Agnone CM, Nieroda CA, Mojzisik C, Hinkle G, Ferrara P, Farrar WB, Bolton J, Thurston MO, Martin EW Jr. Radioimmunoguided surgery in recurrent colorectal cancer: the role of carcinoembryonic antigen, computerized tomography, and physical examination. South Med J. 1989 Oct;82(10):1235-44.
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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.
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 2-Fluoro-2-deoxyglucose in people with Colorectal Neoplasm, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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 United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001568, which also lists 3 linked publications.
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 4 Mar 2008.